Skip to content

Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

Surgery | Laparoscopy | Post-operative Pain | Laparoscopic | Post-operative Recovery | Penumoperitoneum

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.

null

Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 and up

Participation 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;

Study Location

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

Contact Study Team

Primary Contact

Dr. Mara Sobel, MD, MSc

[email protected]
416-586-8273
Study Sponsored By
Mount Sinai Hospital, Canada
Participants Required
More Information
Study ID: NCT06504277