Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

Detailed Description
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After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.

Official Title
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Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial

Conditions
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Pain, Pneumoperitoneum, Inflammatory Response

Intervention / Treatment
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* Procedure: low-pressure pneumoperitoneum
* Procedure: standard-pressure pneumoperitoneum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Elective admission for laparoscopic cholecystectomy Exclusion Criteria: Current or previous diagnosis of acute cholecystitis confirmed by ultrasound previous GI surgeries, except bariatric and anti-reflux surgeries Currently on immunosuppressant agents Pregnancy Breastfeeding Currently diagnosed with drug addiction American Society of Anesthesiologists (ASA) score 3 and more

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-pressure pneumoperitoneum<br>Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg | Procedure: low-pressure pneumoperitoneum<br>* insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg<br>|
| Active Comparator: Standard-pressure pneumoperitoneum<br>Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg | Procedure: standard-pressure pneumoperitoneum<br>* insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of pain with SPS-11 at 6hr post-op | measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op | pre-op to 6 hours post op | 
| change in IL-6 | measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery | pre op to 24 hours post -op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of difficulty of surgery | to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult. analysis done using Chi-square cross table on SPSS V 1.0.0.1406 | start to end of the study, 1 year | 
| assessment of difference in operation time | to look for difference in operation time between the two groups, calculated in minutes. analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406 | start to end of the study, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory marker, Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain