Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC

Sponsor
University of Crete (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172739
Collaborator
(none)
70
1
2
61
1.1

Study Details

Study Description

Brief Summary

Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.

Condition or Disease Intervention/Treatment Phase
  • Drug: Opioid-Based Anesthesia-Analgesia Strategy
  • Drug: Opioid-free Anesthesia-Analgesia Strategy
Phase 4

Detailed Description

Surgical manipulation and one lung ventilation (OLV) exert different and synergic effects to generate an inflammatory response during lung resection surgery. Surgery, such as lobectomies, often leads to severe immunosuppression that in turn can lead to infectious complications and sepsis. Both anesthesia-related and surgery-related perioperative measures may modulate the patient's immune response and lead to the activation of different components of the immune system. Anesthesia-induced activation, in particular of the adaptive immune system, may also induce persistent, postoperative immunosuppression. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis.

Opioid analgesia remains the corner stone of acute pain management in perioperative analgesic regimes. Opioid receptors are not only expressed in the central nervous system to regulate pain perception but also occur on immune and tumour cells. Exogenous opioid administration has been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes.

An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects where at least one factor causes inhibition of central sensitization and at least another factor inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli. This combination of factors has to have a synergistic or additive effect so that best analgesic effects can be achieved with the lowest possible dosage.

Our basic hypothesis is that a perioperative OFA-A strategy on cancer patients undergoing VATS lung surgery for tumour resection will be accompanied by abolished or attenuated immunosuppression. The additional potential clinical implication of a perioperative OFA-A strategy is the avoidance of the onco-proliferative side effects of both exogenous and endogenous opioids, released by cytokine-mediated immune cell activation. Inflammatory response inhibition is expected to reduce the possibility of acute and chronic post-operative pain developement, compared to a perioperative Opioid-Based Anaesthesia- Analgesia (OBA-A) technique. Additionally, the aforementioned inflammatory response inhibition is expected to lead to an overall reduction of overall postoperative pulmonary complications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Administration of a multimodal anaesthetic opioid-free strategy that includes pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is expected to affect the inflammatory and stress response, measured by levels of inflammatory markers and haemodynamic stability, when compared to conventional opioid based techniques. An Opioid-Free Anaesthesia-Analgesia strategy, is expected to also lead to an attenuated immunosuppression, due to the avoidance of opioids, whose administration has been corelated with immunosuppressive effects. An overall decreased inflammatory and stress response as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.Administration of a multimodal anaesthetic opioid-free strategy that includes pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is expected to affect the inflammatory and stress response, measured by levels of inflammatory markers and haemodynamic stability, when compared to conventional opioid based techniques. An Opioid-Free Anaesthesia-Analgesia strategy, is expected to also lead to an attenuated immunosuppression, due to the avoidance of opioids, whose administration has been corelated with immunosuppressive effects. An overall decreased inflammatory and stress response as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Opioid-Based Anaesthesia Analgesia

Premedication: IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/ kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg, Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.

Drug: Opioid-Based Anesthesia-Analgesia Strategy
A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents: Premedication: Midazolam, Anaesthesia induction & maintenance: Midazolam, Propofol, Fentanyl, Cisatracurium or alternatively Rocuronium, Desflurane, Morphine, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine Surgical ward: Morphine, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol
Other Names:
  • Opioid-Based Anesthesia
  • OBA-A
  • Active Comparator: Opioid-Free Anesthesia Analgesia

    Premedication: Pregabalin 150mg 1x2, IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Dexmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/ kg or alternatively Rocuronium 0.6-1.2mg/kg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.5-1.2mcg/kg/h, Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os 1x1 and 25mg 1x1, Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.

    Drug: Opioid-free Anesthesia-Analgesia Strategy
    A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents: Premedication: Pregabalin, Midazolam, Anesthesia induction & maintenance: Midazolam, Dexmedetomidine, Lidocaine, Propofol, Ketamine, Hyoscine, Cisatracurium or alternatively Rocuronium, Magnesium sulphate, Dexamethasone, Desflurane, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine, Surgical ward: Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam, Pregabalin, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol
    Other Names:
  • Opioid-Free Anesthesia
  • OFA-A
  • Outcome Measures

    Primary Outcome Measures

    1. Neutrophil to Lymphocyte ratio (NLR) [Preoperatively]

      Neutrophil to Lymphocyte ratio (NLR) is a prognostic index that predicts patients' overall survival. Higher NLR has been correlated with worse outcome.

    2. Platelet to Lymphocyte ratio (PLR) [Preoperatively]

      Platelet to Lymphocyte ratio (PLR) is a prognostic index that predicts patients' overall survival. Higher PLR has been correlated with worse outcome.

    3. Lymphocyte to monocyte ratio (LMR) [Preoperatively]

      Lymphocyte to monocyte ratio (LMR) is a prognostic index that predicts patients' overall survival. Lower LMR has been correlated with worse outcome.

    4. Advanced Lung Cancer Inflammation Index (ALI) [Preoperatively]

      Advanced Lung Cancer Inflammation Index (ALI) is a prognostic index that predicts patients' recurrence-free survival and overall survival. ALI is calculated as (BMI x Alb / NLR) where BMI = body mass index, Alb = serum albumin, NLR (neutrophil lymphocyte ratio, a marker of systemic inflammation). Higher ALI scores have been correlated with worse outcome.

    5. Systemic Immune Inflammation Index (SII) [Preoperatively]

      Systemic Immune Inflammation Index (SII) is a prognostic index that predicts patients' overall survival. SII is calculated as follows: SII = platelet count × neutrophil/lymphocyte count. Higher SII scores have been correlated with worse outcome.

    6. Prognostic Nutritional Index (PNI) [Preoperatively]

      Prognostic Nutritional Index (PNI) is a prognostic index that predicts patients' overall survival. PNI is calculated as follows: PNI = 10 × serum albumin value (g/dL) + 0.005 × total lymphocyte count (per mm3) in the peripheral blood. Higher PNI scores have been correlated with worse outcome.

    7. Surgical Stress Response - IL-6 - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    8. Surgical Stress Response - IL-6 - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    9. Surgical Stress Response - IL-6 - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    10. Surgical Stress Response - IL-8 - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    11. Surgical Stress Response - IL-8 - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    12. Surgical Stress Response - IL-8 - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    13. Surgical Stress Response - IL-10 - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    14. Surgical Stress Response - IL-10 - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    15. Surgical Stress Response - IL-10 - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    16. Surgical Stress Response - TNF-a - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    17. Surgical Stress Response - TNF-a - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    18. Surgical Stress Response - TNF-a - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    19. Surgical Stress Response - CRP - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    20. Surgical Stress Response - CRP - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    21. Surgical Stress Response - CRP - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    22. Surgical Stress Response - WBC - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    23. Surgical Stress Response - WBC - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    24. Surgical Stress Response - WBC - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    25. Surgical Stress Response - AVP - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    26. Surgical Stress Response - AVP - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    27. Surgical Stress Response - AVP - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    28. Surgical Stress Response - cortisol - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    29. Surgical Stress Response - cortisol - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    30. Surgical Stress Response - cortisol - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    31. Surgical Stress Response - HIF-1α- preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    32. Surgical Stress Response - HIF-1α - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    33. Surgical Stress Response - HIF-1α - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    34. Surgical Stress Response - VEGF- preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    35. Surgical Stress Response - VEGF- end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    36. Surgical Stress Response - VEGF - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    37. Surgical Stress Response - NF-κB - preoperatively [Preoperatively (as a baseline)]

      Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    38. Surgical Stress Response - NF-κB - end of surgery [End of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    39. Surgical Stress Response - NF-κB - 24 hours after the end of surgery [24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)]

      Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    40. Haemodynamic Stability - Mean PR [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data.

    41. Haemodynamic Stability - Minimum PR [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR will be reported for each patient, extracted from the collected data.

    42. Haemodynamic Stability - Maximum PR [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data.

    43. Haemodynamic Stability - Standard Deviation PR [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation PR will be reported for each patient, extracted from the collected data.

    44. Haemodynamic Stability - PR Change Induction [1 minute after anesthesia induction, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    45. Haemodynamic Stability - PR Change Incision [1 minute after surgical incision, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    46. Haemodynamic Stability - Mean SBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data.

    47. Haemodynamic Stability - Minimum SBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data.

    48. Haemodynamic Stability - Maximum SBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data.

    49. Haemodynamic Stability - Standard Deviation SBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SBP will be reported for each patient, extracted from the collected data.

    50. Haemodynamic Stability - SBP Change Induction [1 minute after anesthesia induction, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    51. Haemodynamic Stability - SBP Change Incision [1 minute after surgical incision, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    52. Haemodynamic Stability - Mean DBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data.

    53. Haemodynamic Stability - Minimum DBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data.

    54. Haemodynamic Stability - Maximum DBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data.

    55. Haemodynamic Stability - Standard Deviation DBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation DBP will be reported for each patient, extracted from the collected data.

    56. Haemodynamic Stability - DBP change induction [1 minute after anesthesia induction, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    57. Haemodynamic Stability - DBP change incision [1 minute after surgical incision, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    58. Haemodynamic Stability - Mean MBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data.

    59. Haemodynamic Stability - Minimum MBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data.

    60. Haemodynamic Stability - Maximum MBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data.

    61. Haemodynamic Stability - Standard Deviation MBP [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation MBP will be reported for each patient, extracted from the collected data.

    62. Haemodynamic Stability - MBP change induction [1 minute after anesthesia induction, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    63. Haemodynamic Stability - MBP change incision [1 minute after surgical incision, compared to 1 minute prior]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    64. Haemodynamic Stability - Mean CO [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data.

    65. Haemodynamic Stability - Minimum CO [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data.

    66. Haemodynamic Stability - Maximum CO [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data.

    67. Haemodynamic Stability - Standard Deviation CO [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CO will be reported for each patient, extracted from the collected data.

    68. Haemodynamic Stability - Mean CI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data.

    69. Haemodynamic Stability - Minimum CI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data.

    70. Haemodynamic Stability - Maximum CI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data.

    71. Haemodynamic Stability - Standard Deviation CI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CI will be reported for each patient, extracted from the collected data.

    72. Haemodynamic Stability - Mean SV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data.

    73. Haemodynamic Stability - Minimum SV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data.

    74. Haemodynamic Stability - Maximum SV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data.

    75. Haemodynamic Stability - Standard Deviation SV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SV will be reported for each patient, extracted from the collected data.

    76. Haemodynamic Stability - Mean SVV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data.

    77. Haemodynamic Stability - Minimum SVV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data.

    78. Haemodynamic Stability - Maximum SVV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data.

    79. Haemodynamic Stability - Standard Deviation SVV [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVV will be reported for each patient, extracted from the collected data.

    80. Haemodynamic Stability - Mean SVI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data.

    81. Haemodynamic Stability - Minimum SVI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data.

    82. Haemodynamic Stability - Maximum SVI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data.

    83. Haemodynamic Stability - Standard Deviation SVI [Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVI will be reported for each patient, extracted from the collected data.

    84. Haemodynamic Stability - Tachycardia [Intraoperatively, assessed up to 4 hours.]

      Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative tachycardia.

    85. Haemodynamic Stability - Bradycardia [Intraoperatively, assessed up to 4 hours.]

      Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative bradycardia.

    86. Haemodynamic Stability - Hypotension [Intraoperatively, assessed up to 6 hours.]

      Intraoperative Hypotension (defined as SBP≤100mmHg or ≤70% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension.

    87. Haemodynamic Stability - Hypertension [Intraoperatively, assessed up to 6 hours.]

      Intraoperative Hypertension (defined as SBP ≥130% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension.

    88. Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystalloid Fluid Requirements.

    89. Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.

    90. Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated Red Blood Cell unit Requirements.

    91. Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.

    92. Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.

    93. Haemodynamic Stability - Blood Loss - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss

    94. Haemodynamic Stability - Fluid Balance - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance

    95. Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements

    96. Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements

    97. Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements

    98. Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements

    99. Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements

    100. Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements

    101. Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively [Intraoperatively, assessed up to 6 hours.]

      Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements

    Secondary Outcome Measures

    1. Acute postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively [Immediately postoperatively]

      Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    2. Acute postoperative pain - Numerical Rating Scale (NRS) - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    3. Acute postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    4. Acute postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    5. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively [Immediately postoperatively]

      Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    6. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    7. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    8. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    9. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported

    10. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported

    11. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported

    12. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    13. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    14. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    15. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported

    16. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported

    17. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported

    18. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported

    19. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported

    20. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be: Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported

    21. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported

    22. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported

    23. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported

    24. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported

    25. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported

    26. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported

    27. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting Better" will be reported

    28. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting Better" will be reported

    29. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be: Getting worse About the same Getting better The percentage of patients that report pain that is "Getting Better" will be reported

    30. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported

    31. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported

    32. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported

    33. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Effective, just about right" will be reported

    34. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Effective, just about right" will be reported

    35. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Effective, just about right" will be reported

    36. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Would like to reduce medication" will be reported

    37. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Would like to reduce medication" will be reported

    38. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be: Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Would like to reduce medication" will be reported

    39. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    40. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    41. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    42. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    43. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    44. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    45. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    46. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    47. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    48. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    49. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    50. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be: Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    51. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    52. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    53. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    54. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    55. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    56. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    57. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day [First postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    58. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    59. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be: Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    60. Analgesic Requirements - First postoperative day [First postoperative day]

      Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    61. Analgesic Requirements - Second postoperative day [Second postoperative day]

      Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    62. Analgesic Requirements - Third postoperative day [Third postoperative day]

      Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    63. Postoperative Pulmonary Complications - Aspiration Pneumonitis [From the first postoperative day, until the fifth postoperative day]

      Aspiration pneumonitis (defined as respiratory failure after the inhalation of regurgitated gastric contents)

    64. Postoperative Pulmonary Complications - Moderate respiratory failure [From the first postoperative day, until the fifth postoperative day]

      Moderate respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen > 2 L/min)

    65. Postoperative Pulmonary Complications - Severe respiratory failure [From the first postoperative day, until the fifth postoperative day]

      Severe respiratory failure (need for non-invasive or invasive mechanical ventilation due to poor oxygenation)

    66. Postoperative Pulmonary Complications - ARDS [From the first postoperative day, until the fifth postoperative day]

      Adult respiratory distress syndrome (mild, moderate, or severe according to the Berlin definition)

    67. Postoperative Pulmonary Complications - Pulmonary Infection [From the first postoperative day, until the fifth postoperative day]

      Pulmonary infection (defined as new or progressive radiographic infiltrate plus at least two of the following: antibiotic treatment, tympanic temperature > 38 °C, leukocytosis or leucopenia (white blood cell (WBC) count < 4000 cells/mm3 or > 12,000 cells/mm3) and/or purulent secretions)

    68. Postoperative Pulmonary Complications - Atelectasis [From the first postoperative day, until the fifth postoperative day]

      Atelectasis (suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung)

    69. Postoperative Pulmonary Complications - Cardiopulmonary edema [From the first postoperative day, until the fifth postoperative day]

      Cardiopulmonary edema (defined as clinical signs of congestion, including dyspnea, edema, rales, and jugular venous distention, with the chest x-ray demonstrating increase in vascular markings and diffuse alveolar interstitial infiltrates)

    70. Postoperative Pulmonary Complications - Pleural effusion [From the first postoperative day, until the fifth postoperative day]

      Pleural effusion (chest x-ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows)

    71. Postoperative Pulmonary Complications - Pneumothorax [From the first postoperative day, until the fifth postoperative day]

      Pneumothorax (defined as air in the pleural space with no vascular bed surrounding the visceral pleura)

    72. Postoperative Pulmonary Complications - Pulmonary Infiltrates [From the first postoperative day, until the fifth postoperative day]

      Pulmonary infiltrates (chest x-ray demonstrating new monolateral or bilateral infiltrate without other clinical signs)

    73. Postoperative Pulmonary Complications - Prolonged air leakage [From the first postoperative day, until the fifth postoperative day]

      Prolonged air leakage (air leak requiring at least 7 days of postoperative chest tube drainage)

    74. Postoperative Pulmonary Complications - Purulent pleuritic [From the first postoperative day, until the fifth postoperative day]

      Purulent pleuritic (receiving antibiotics for a suspected infection, as far as not explained by the preoperative patient condition alone)

    75. Postoperative Pulmonary Complications - Pulmonary embolism [From the first postoperative day, until the fifth postoperative day]

      Pulmonary embolism (as documented by pulmonary arteriogram or autopsy, or supported by ventilation/perfusion radioisotope scans, or documented by echocardiography and receiving specific therapy)

    76. Postoperative Pulmonary Complications - Lung hemorrhage [From the first postoperative day, until the fifth postoperative day]

      Lung hemorrhage (bleeding through the chest tubes requiring reoperation, or three or more red blood cell packs)

    77. Chronic postoperative pain - Pain Detect [Three months after the end of surgery]

      Evaluation of patients' pain using the standardized "Pain Detect" questionnaire. The "Pain Detect" questionnaire has been standardized for screening the presence of a neuropathic pain component. Patients will be interviewed by phone interview, 3 months after the end of surgery. The possible score a patient can have, ranges from 0 to 38.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients undergoing elective VATS lobectomy

    • early stage NSCLC (up to T3N1M0)

    Exclusion Criteria:
    • Immunocompromised patients

    • previous lung surgery

    • preoperative corticosteroid or immunosuppressive drug use

    • uncontrolled Diabetes Mellitus

    • cardiac failure (NYHA 3 and 4)

    • preoperative infection (CRP >5mg/ml, WBC >10x10^9/L)

    • preoperative anemia (Hb<12g/dl)

    • chronic inflammatory diseases

    • inflammatory bowel disease

    Group-specific exclusion criteria:
    • OFA-Α: perioperative opioid administration, within the study period

    • OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Crete Heraklion Crete Greece 71110

    Sponsors and Collaborators

    • University of Crete

    Investigators

    • Study Chair: Vasileia Nyktari, MD, PhD, University of Crete, Medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Periklis Vasilos, Principal Investigator, University of Crete
    ClinicalTrials.gov Identifier:
    NCT05172739
    Other Study ID Numbers:
    • OFA-Thoracic
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Dec 29, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Periklis Vasilos, Principal Investigator, University of Crete
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 29, 2021