Actively Recruiting
A Randomized Controlled Trial Comparing Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Benign Gynecologic Laparoscopic Surgery
Led by Mount Sinai Hospital, Canada · Updated on 2025-07-31
82
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
Sponsors
M
Mount Sinai Hospital, Canada
Lead Sponsor
W
Women's College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low pressure (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum during benign gynecologic laparoscopic surgery. This single-center, double-blind randomized controlled trial aims to understand how these pressures influence post-operative shoulder tip pain, with the primary focus on pain measured one day after surgery. The study also looks at secondary outcomes including pain at earlier time points, quality of recovery, nausea, bloating, medication use, and surgical factors such as time and blood loss. Participants will be randomly assigned to one of two groups: one receiving standard pressure pneumoperitoneum and the other receiving low pressure pneumoperitoneum. The pressure setting will be maintained throughout the surgery, and the surgical team will remain blinded to which pressure is being used. Standard peri-operative care will be provided to all patients. The study will collect data on pain, recovery quality, medication use, surgical visibility, anesthetist satisfaction, and any complications or adverse effects. Participants will be monitored for post-operative pain, nausea, and medication use while in the recovery unit and contacted on the first day after surgery for further pain assessments and recording of narcotic consumption. Researchers will also collect information on surgical time, blood loss, and any complications. The total participation involves surgery day assessments and follow-up phone contact on post-operative day one. The study aims to provide detailed information about recovery and pain management following gynecologic laparoscopic procedures.
CONDITIONS
Brief Title
Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older
- Able to provide informed consent
- Signed and dated informed consent form
- Willing to comply with all study procedures
- Scheduled for unilateral or bilateral salpingo-oophorectomy, salpingectomy, or ovarian cystectomy
You will not qualify if you...
- Previous midline laparotomy surgery
- Gynecological cancer beyond stage 1
- Chronic pain conditions
- Known diagnosis or intra-operative evidence of endometriosis
- Fibromyalgia diagnosis
- Body mass index (BMI) greater than 50
- Language barrier preventing communication
- Unable to communicate or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 hours before surgery
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Duration of surgery (day surgery)
Participants undergo benign gynecologic laparoscopic surgery with either low (10 mm Hg) or standard (15 mm Hg) pressure pneumoperitoneum during the procedure.
1 surgical procedure visit (in-person)
Duration - Up to 1 day after surgery
Participants are assessed for shoulder tip pain, generalized pain, nausea, vomiting, bloating, and narcotic use in the post-anesthesia care unit and on the day following surgery.
1 immediate post-operative visit and 1 follow-up phone call on post-operative day 1
Trial Site Locations
Total: 1 location
1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
Research Team
S
Sara Hojabri, MBBCHBAO
M
Mara Sobel, MD, MSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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