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

University of Jordan

Status: Completed

Conditions: Pneumoperitoneum; Inflammatory Response; Pain

Treatments: Procedure: standard-pressure pneumoperitoneum; Procedure: low-pressure pneumoperitoneum

Study type: Interventional

Funder types: Other

Identifiers

NCT05530564

10/2019/1115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Low-pressure pneumoperitoneum

Experimental group

Description:

Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Treatment:

Procedure: low-pressure pneumoperitoneum

Standard-pressure pneumoperitoneum

Active Comparator group

Description:

Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg

Treatment:

Procedure: standard-pressure pneumoperitoneum