Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy: A Prospective Observational Study
Study Details
Study Description
Brief Summary
Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative pain, then a more aggressive pain management strategy can be adopted perioperatively. This would improve patient satisfaction and prevent poor outcomes such as chronic pain after surgery. Therefore, our primary aim is to find out whether presence of pre-existing preoperative pain would predict moderate-severe acute pain after laparoscopic cholecystectomy. Moreover, we plan to use Patient Reported Outcomes Measurement Information System (PROMIS) scale to assess preoperative pain intensity and pain-related behaviors.
Primary &Secondary Objectives:
Primary objectives To investigate the association between preexisting preoperative pain (more than 3 months duration) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
Secondary objectives
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To investigate the association between preoperative PROMIS domain (PROMIS pain intensity score, PROMIS pain interference score, PROMIS pain behavioural score) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
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To investigate the association between preexisting preoperative pain and postoperative total opioid consumption.
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To identify the risk factors associated with postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
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To compare postoperative pain interference scores between patients who reports moderate-severe pain and those who do not.
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To identify the risk factors associated with shoulder tip pain after laparoscopic cholecystectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Patients who are 18 years of age and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled in this prospective observational study. Perioperative anesthesia management will be standardized for all patients.
Variables such as age, sex, preexisting preoperative pain (chronic or subacute), preoperative PROMIS pain intensity, PROMIS behavior, PROMIS interference, PROMIS depression, PROMIS sleep disturbance, APAIS score, catastrophizing pain score, neuroticism (EPQRS score), preoperative pain sensitivity, an expectation of the postoperative pain and intraoperative surgical variables will be recorded.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| preexisting preoperative chronic pain Patients with preexisting preoperative chronic pain (more than 3 months duration). |
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| preexisting preoperative sub-acute pain Patients with preexisting preoperative sub-acute pain (less than 3 months duration). |
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| No pain preoperatively Patients without preexisting preoperative pain. |
Outcome Measures
Primary Outcome Measures
- Occurrence of acute moderate to severe postoperative pain. [up to 24 hours postoperatively.]
numerical pain rating scale (NPRS) more than or equal to 4.
Secondary Outcome Measures
- Total opioids consumed in morphine equivalent (mg). [up to 24 hours postoperatively.]
morphine equivalents in mg
Eligibility Criteria
Criteria
Inclusion Criteria:
All patients undergoing laparoscopic cholecystectomy
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Age group (more than or equal to 18 years)
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All ASA physical status patients.
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Ability to use NPRS scale, PROMIS scale, pain catastrophizing scale, APAIS, neuroticism EPQRS scale, and to understand and follow simple instructions.
Exclusion Criteria:
All patient with
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Not willing to participate in the study
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Severe Neurological and Psychiatric disorder(eg. dementia)
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Pregnant women
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Acute cholecystitis managed conservatively.
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Cognitive impairments (lack of capacity to provide informed consent)
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Choledocholithiasis
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Features of obstructive jaundice.
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Unable to communicate (eg. Language barrier or deaf)
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Open cholecystectomy or laparoscopic cholecystectomy converted to open cholecystectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | B.P. Koirala Institute of Health Sciences | Dharān Bāzār | Province O1 | Nepal | 56700 |
Sponsors and Collaborators
- B.P. Koirala Institute of Health Sciences
Investigators
- Study Chair: Asish Subedi, MD, BP Koirala Institute of Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRC/2283/022