Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06504277

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - Up to 2 hours before surgery

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

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)

Post-operative Follow-up

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

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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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