POPARTS: Post-Operative Pain After Recovery in Thoracic Surgery

Sponsor

University of Trieste (Other)

Overall Status

Unknown status

CT.gov ID

NCT04300660

Collaborator

(none)

250

Enrollment

Location

29.2

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. In thoracic surgery, chronic neuropathic pain is represented by Post-Thoracotomic Pain Syndrome (PTPS), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. Currently, in literature, the prevalence of PTPS is extremely variable. This prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain Post Operative Pain Thoracic Surgery	Other: neuropathic pain after thoracic surgery

Detailed Description

For each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - Euro QoL 5D5L1) will be recorded. Surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. In the 48 hours following the surgery (in the Recovery Room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated NRS) and those relating to any complications. The total amount of morphine administered to the patient in the first 48 hours will also be recorded. Each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. In this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

POPARTS Study- Post-Operative Pain After Recovery in Thoracic Surgery: Evaluation of the Persistence of Painful Symptoms and the Incidence of Neuropathic Pain After Resective Lung Surgery

Actual Study Start Date :

Oct 25, 2017

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Apr 1, 2020

Outcome Measures

Primary Outcome Measures

Incidence of persistent post-operative pain after thoracic surgery [the data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgery]
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Incidence of persistent post-operative pain after thoracic surgery [the data needed to analyze the incidence and characteristics of pain will be collected at 1 month after surgery]
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Incidence of Chronic Pain after thoracic surgery [The data needed to analyze the presence of chronic pain will be collected at 3 months after surgery]
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Incidence of Chronic Pain after thoracic surgery [The data needed to analyze the presence of chronic pain will be collected at 6 months after surgery]
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course [The data neede to analyze the presence of neuropathic pain will be collected at a week after the surgery]
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course [The data neede to analyze the presence of neuropathic pain will be collected at a month after the surgery]
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course [The data neede to analyze the presence of neuropathic pain will be collected at 3 months after the surgery]
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course [The data neede to analyze the presence of neuropathic pain will be collected at 6 months after the surgery]
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.

Secondary Outcome Measures

Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgery [during the intraoperative phase, data relating to the surgical techniques performed are collected]
the aim of this objective is to analyze whether different surgical techniques (more or less invasive) play a role in the onset of chronic pain after thoracic surgery
Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgery [during the intraoperative phase, data relating to the surgical techniques performed are collected]
the aim of this objective is to analyze whether different surgical techniques (more or less invasive) play a role in the quality of life after thoracic surgery
Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic pain [data relating to this objective are collected in the intraoperative, 24 hours after surgery and subsequent telephone interviews at 1 week, 1, 3 and 6 months after thoracic surgery]
the aim of this objective is to analyze whether different anesthesiological techniques play a role in the onset of chronic or neuropathic pain after thoracic surgery. The techniques of locoregional anesthesia performed and the drugs used both during surgery and in the postoperative phase are analyzed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Patient's consent to the trial
Candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, VATS)