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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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

Official title: 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

Run by Mount Sinai Hospital, Canada · NCT06504277 · Data updated 2026-11-12

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.

More Post Operative Pain trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment82 (estimated)
SponsorMount Sinai Hospital, Canada
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedJuly 2, 2025
Main results expectedJuly 10, 2026
Study endsSeptember 15, 2026
Registry record updatedJuly 31, 2025
Trial IDNCT06504277 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Women's College Hospital
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.