PloS one · 2026
Low pressure (8 mmHg) pneumoperitoneum does not significantly reduce postoperative visual analog scale score after laparoscopic cholecystectomy: Randomized trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Safta Amine Ben, Nasri Salsabil, Samaali Imen, Dougaz Wajih, Bousassi Raja, Taher Hajer, Khalfallah Mehdi, Dziri Chadli, Nouira Ramzi
Аннотация
BACKGROUND: Low-pressure pneumoperitoneum (LPP) has been proposed to improve postoperative pain in laparoscopic surgery. This randomized controlled trial (RCT) aimed to evaluate the impact of LPP versus standard-pressure pneumoperitoneum (SPP) on postoperative pain and surgical outcomes during laparoscopic cholecystectomy.
METHODS: A randomized, controlled, double-blind trial was performed between November 12, 2024 and December 31, 2025. Patients scheduled for elective laparoscopic cholecystectomy (LC) were randomized into two groups: LPP group (8 mmHg) versus SPP group (14 mmHg). The primary outcome was postoperative pain assessed by the Visual Analogue Scale (VAS) at 6 hours. Secondary outcomes included operative time, analgesic consumption, postoperative nausea and vomiting (PONV), and surgical complications. Data were analyzed using an intention-to-treat approach. This trial has been registered at ClinicalTrials.gov (NCT06685250) on November 11, 2024.
RESULTS: One hundred sixty consecutive patients were enrolled. There was no statistically significant difference in median VAS pain scores at 6 hours (3 vs. 4; p = 0.221), 12 hours (2 vs. 3; p = 0.074), or 24 hours (1 vs. 2; p = 0.128) postoperatively. However, the mean consumption of paracetamol during the first 24 hours was significantly lower in the LPP group compared to the SPP group (1.04 ± 0.906 vs. 1.35 ± 0.873; p = 0.014). Operative times were similar (59.9 ± 27.5 vs. 58.2 ± 22.4 minutes; p = 0.880). No conversion to laparotomy or major morbidities were recorded.
CONCLUSION: LPP (8 mmHg) was feasible without increasing operative duration. It did not show a statistically significant reduction in VAS pain scores at 6 hours. Larger studies are required to confirm safety equivalence regarding rare surgical complications.
METHODS: A randomized, controlled, double-blind trial was performed between November 12, 2024 and December 31, 2025. Patients scheduled for elective laparoscopic cholecystectomy (LC) were randomized into two groups: LPP group (8 mmHg) versus SPP group (14 mmHg). The primary outcome was postoperative pain assessed by the Visual Analogue Scale (VAS) at 6 hours. Secondary outcomes included operative time, analgesic consumption, postoperative nausea and vomiting (PONV), and surgical complications. Data were analyzed using an intention-to-treat approach. This trial has been registered at ClinicalTrials.gov (NCT06685250) on November 11, 2024.
RESULTS: One hundred sixty consecutive patients were enrolled. There was no statistically significant difference in median VAS pain scores at 6 hours (3 vs. 4; p = 0.221), 12 hours (2 vs. 3; p = 0.074), or 24 hours (1 vs. 2; p = 0.128) postoperatively. However, the mean consumption of paracetamol during the first 24 hours was significantly lower in the LPP group compared to the SPP group (1.04 ± 0.906 vs. 1.35 ± 0.873; p = 0.014). Operative times were similar (59.9 ± 27.5 vs. 58.2 ± 22.4 minutes; p = 0.880). No conversion to laparotomy or major morbidities were recorded.
CONCLUSION: LPP (8 mmHg) was feasible without increasing operative duration. It did not show a statistically significant reduction in VAS pain scores at 6 hours. Larger studies are required to confirm safety equivalence regarding rare surgical complications.