NCT05530564

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumoperitoneum
• Pain
• Inflammatory Response

Interventions

Type	Name	Description
PROCEDURE	low-pressure pneumoperitoneum	insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
PROCEDURE	standard-pressure pneumoperitoneum	insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2022-09-07
• Last updated: 2022-09-07

Locations

1 site across 1 country: Jordan