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Recruiting Not applicable

Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

NCT06504277 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-07-02
Last updated
2025-07-31

Condition(s) studied

SurgeryLaparoscopicLaparoscopyPenumoperitoneumPost-operative PainPost-operative Recovery

Investigational drug(s) / intervention(s)

Low Pressure PenumoperitoneumStandard Pressure Group (No intervention- active comparator)

Low Pressure Penumoperitoneum: Maintained Pneumoperitoneum with low pressure of 10 mm Hg

Standard Pressure Group (No intervention- active comparator): Maintained Pneumoperitoneum at standard pressure of 15 mm Hg

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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;

Primary outcome measure(s)

  • Shoulder Tip Pain — Post-op day 1
    The primary endpoint is post-operative shoulder tip pain measured on post-op day 1 following surgery by a self-administered NRS (numeric rating score) for pain, on a scale from 0 (no pain) to 10 (worst pain imaginable).

Trial sites (1)

FacilityCityRegionStatus
Women's College Hospital Toronto Ontario Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06504277 on ClinicalTrials.gov ↗ ← All trials in Canada