Lower versus standard abdominal gas pressure to reduce shoulder pain after gynecologic laparoscopy

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

This trial will test whether using lower gas pressure (10 mm Hg) instead of standard pressure (15 mm Hg) during benign gynecologic laparoscopic surgery reduces shoulder-tip pain afterwards.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mount Sinai Hospital, Canada (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06504277 on ClinicalTrials.gov

What this trial studies

This is a single-center, double-blind, parallel-group randomized trial at Women's College Hospital comparing low (10 mm Hg) versus standard (15 mm Hg) pneumoperitoneum in benign gynecologic laparoscopic procedures. Participants are randomized to one of the two pressures, with surgeons blinded to the assigned insufflation pressure, and post-operative recovery and pain scores recorded. Primary outcome is shoulder-tip pain on post-operative day one, and secondary outcomes include early shoulder pain, overall pain, nausea, bloating, rescue analgesia use, intraoperative metrics, and rate of needing to increase pressure. The study uses a convenience sample of eligible adults scheduled for specified gynecologic laparoscopic procedures.

Who should consider this trial

Good fit: Adults (≥18 years) able to give informed consent who are scheduled for benign gynecologic laparoscopic procedures such as salpingo-oophorectomy, salpingectomy, or ovarian cystectomy are eligible.

Not a fit: Patients with prior midline laparotomy, known or operative evidence of endometriosis, chronic pain disorders or fibromyalgia, BMI over 50, gynecologic cancer beyond stage I, language or communication barriers, or inability to consent are excluded and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, using lower insufflation pressure could reduce shoulder-tip pain after surgery and improve early recovery for patients undergoing benign gynecologic laparoscopy.

How similar studies have performed: Previous randomized studies of low-pressure pneumoperitoneum have shown mixed but often favorable reductions in shoulder-tip pain, so the approach has some supporting evidence though it is not definitively settled.

Eligibility criteria

Inclusion Criteria: The participant must meet all of the inclusion criteria to eligible for this clinical trial:

1. All ages \> or = to 18 years old;
2. Must be deemed to have capacity to provide informed consent;
3. Must sign and date the informed consent form;
4. Stated willingness to comply with all study procedures;
5. Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this clinical trial:

1. Previous midline laparotomy;
2. Gynecological cancer beyond stage 1 disease;
3. Chronic pain;
4. Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
5. Fibromyalgia;
6. BMI \>50;
7. Language barrier;
8. Inability to communicate or provide informed consent;

Where this trial is running

Toronto, Ontario

• Women's College Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Sara Hojabri, MBBCHBAO

Conditions Surgery; Laparoscopic; Laparoscopy; Penumoperitoneum; Post-operative Pain; Post-operative Recovery