Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
A Randomized Controlled Trial (RCT) Comparing the Effect of Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Patients Undergoing Laparoscopic Gynecologic Surgery for Benign Indications
Mount Sinai Hospital, Canada
82 participants
Jul 2, 2025
INTERVENTIONAL
Conditions
Summary
This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.
Eligibility
Inclusion Criteria5
- All ages \> or = to 18 years old;
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;
Exclusion Criteria8
- Previous midline laparotomy;
- Gynecological cancer beyond stage 1 disease;
- Chronic pain;
- Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
- Fibromyalgia;
- BMI \>50;
- Language barrier;
- Inability to communicate or provide informed consent;
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Interventions
Maintained Pneumoperitoneum with low pressure of 10 mm Hg
Maintained Pneumoperitoneum at standard pressure of 15 mm Hg
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06504277