Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post 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 Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.

Conditions
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Pneumoperitoneum, Pain, Inflammation

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: Supportive Care
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<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<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 |
| --- | --- | --- |
| change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 12-hr post-op) - (baseline pain score assessed at 6-hr post-op) | baseline and 12 hours post-op | 
| change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 24-hr post-op) - (baseline pain score assessed at 6-hr post-op) | baseline and 24 hours post-op | 
| change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at post-op day 7) - (baseline pain score assessed at 6-hr post-op) | baseline and 7 days post-op | 
| change from baseline in WBC count at 24hr post op | calculate the rise in white blood cycles count as inflammatory marker post-op in 1000 cells per cubic millimeter of blood. change = (post-op WBC count) - (baseline WBC count) | baseline and 24 hours post-op | 
| change from baseline in Plt count at 24hr post op | calculate the rise in platelets count as inflammatory marker post-op in × 10^9/L of blood change = (post-op Plt count) - (baseline Plt count) | baseline and 24 hours post-op | 
| change from baseline in ESR value at 24hr post op | calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR) | baseline and 24 hours post-op | 
| change from baseline in CRP level at 24hr post op | calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP) | baseline and 24 hours post-op | 
| change from baseline in Alb level at 24hr post op | calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb) | baseline and 24 hours post-op | 
| change from baseline in cortisol level at 4hr post op | calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol ) | baseline and 4 hours post-op | 
| change from baseline in IL-6 level at 24hr post op | calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6) | baseline and 24 hours post-op | 
| change from baseline in IL-17 level at 24hr post op | calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17) | baseline and 24 hours post-op | 
| change from baseline in IL-1 level at 24hr post op | calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1) | baseline and 24 hours post-op | 
| change from baseline in TNF level at 24hr post op | calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF) | baseline and 24 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in surgery difficulty level among two groups | assessing level of surgery difficulty between low and standard pressure pneumoperitoneum groups. Difficulty was self reported by operating surgeon as easy (score=1), moderate (score=2), or difficult (score=3). Difference assessed by calculating average between groups | through study completion, an average of 1 year | 
| Difference in surgery time among two groups | assessing difference in insufflation time calculated in minutes between low and standard pressure pneumoperitoneum groups. insufflation time was calculated from time of creation of pneumoperitoneum to deflation of the abdomen. Difference assessed by calculating average between groups | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-pressure pneumoperitoneum, lap chole