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

Not Applicable

Completed

• Conditions: Pain; Pneumoperitoneum; Inflammatory Response
• Interventions: Procedure: standard-pressure pneumoperitoneum; Procedure: low-pressure pneumoperitoneum

• Registration Number: NCT05530564
• Lead Sponsor: University of Jordan

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Study First Submitted: 2022-08-27
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-03
• Last Update Submitted: 2022-09-03
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-pressure pneumoperitoneum	standard-pressure pneumoperitoneum	Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Low-pressure pneumoperitoneum	low-pressure pneumoperitoneum	Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Primary Outcome Measures

Name	Time	Method
assessment of pain with SPS-11 at 6hr post-op	pre-op to 6 hours 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
change in IL-6	pre op to 24 hours post -op	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

Secondary Outcome Measures

Name	Time	Method
assessment of difficulty of surgery	start to end of the study, 1 year	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
assessment of difference in operation time	start to end of the study, 1 year	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

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jubaiha, Jordan