Effect of low-pressure pneumoperitoneum on pain and inflammation in laparoscopic cholecystectomy: a randomized controlled clinical trial

Abstract

Objective: We aim to assess the effect of low-pressure pneumoperitoneum on post operative pain and ten of the known inflammatory markers.

Background: The standard of care pneumoperitoneum set pressure in laparoscopic cholecystectomy is set to 12-14 mmHg, but many societies advocate to operate at the lowest pressure allowing adequate exposure of the operative field. Many trials have described the benefits of operating at a low-pressure pneumoperitoneum in terms of lower post operative pain, and better hemodynamic stability. But only few describe the effects on inflammatory markers and cytokines.

Methods: A prospective, double-blinded, randomised, controlled clinical trial, including patients who underwent elective laparoscopic cholecystectomy. Patients randomised into low-pressure (8-10 mmHg) vs. standard-pressure (12-14 mmHg) with an allocation ratio of 1:1. Perioperative variables were collected and analysed.

Results: one hundred patients were allocated, 50 patients in each study arm. Low-pressure patients reported lower median pain score 6-hour post operatively (5 vs. 6, p-value = 0.021) in comparison with standard-pressure group. Eight out of 10 inflammatory markers demonstrated better results in low-pressure group in comparison with standard-pressure, but the effect was not statistically significant. Total operative time and surgery difficulty was not significantly different between the two groups even in the hands of inexperienced surgeons.

Conclusion: low-pressure laparoscopic cholecystectomy is associated with less post operative pain and lower rise of inflammatory markers. It is feasible with comparable complications to the standard of care. Registered on ClinicalTrials.gov (NCT05530564/ September 7th, 2022).

Keywords: Clinical trial; Inflammatory marker; Laparoscopic cholecystectomy; Low pressure insufflation; Pain; Pneumoperitoneum.

Fig. 1

Line graph of post-operative pain score [Red line represents standard-pressure group, green line represents low-pressure group. A difference is observed at the 6-hour time point, but the mean of pain score at 12-hour and 24-hour time points is equal]

Fig. 2

Box plot of post-operative pain at 6-houre [showing box plot of pain score at 6-hour time point, the horizontal line represents median score which is different between the two groups]

Fig. 3

Box plot of mean difference in free serum cortisol level [Box plot shows difference in the median of change in free cortisol levels between the two groups standard Vs low pressure group, with significant difference]