Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

NCT06504277 | Recruiting

• 1 other identifier: 2023-0008-E
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Shoulder Tip Pain

  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).

  Post-op day 1

Secondary Outcomes (10)

• Shoulder Tip Pain (Short-term)

  1 and 2 hours after surgery

• Quality of Recovery (QoR) score

  Post-op day 1

• Generalized Pain Score

  1, 2 hours post-op and post-op day 1

• Incidence of Nausea and Vomitting

  1, 2 hours post-op and post-op day 1

• Narcotic use

  Post-op day 1

Study Arms (2)

Standard Pressure

ACTIVE COMPARATOR

Patients undergoing laparosocpy at standard pressure (15 mm Hg)

Other: Standard Pressure Group (No intervention- active comparator)

Low Pressure

EXPERIMENTAL

Patients undergoing experimental intervention of low pressure pneumoperitoneum (10 mm Hg)

Procedure: Low Pressure Penumoperitoneum

Interventions

Low Pressure Penumoperitoneum PROCEDURE

Maintained Pneumoperitoneum with low pressure of 10 mm Hg

Low Pressure

Standard Pressure Group (No intervention- active comparator) OTHER

Maintained Pneumoperitoneum at standard pressure of 15 mm Hg

Standard Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ages \> or = to 18 years old;
• Must be deemed to have capacity to provide informed consent;
• Must sign and date the informed consent form;
• Stated willingness to comply with all study procedures;
• Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;

You may not qualify if:

• Previous midline laparotomy;
• Gynecological cancer beyond stage 1 disease;
• Chronic pain;
• Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
• Fibromyalgia;
• BMI \>50;
• Language barrier;
• Inability to communicate or provide informed consent;

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Women's College Hospital: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Sara Hojabri, MBBCHBAO

CONTACT

6474047614; sara.hojabri@mail.utoronto.ca

Mara Sobel, MD, MSC

CONTACT

9055155186; mara.sobel@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants will be randomized on the day of surgery, and the research nurse will set the insufflation pressure to the pre-randomized pressure identified in the envelope. The surgeon, research team, participants and data analysts will be blinded to treatment group. Study participants will be randomized on the day of surgery. After Veress-needle insufflation and laparoscopic port insertion at a pneumoperitoneum of 20mmHg (standard entry pressure), the patient will be placed in Trendelenberg position. At this time, the research nurse will set the insufflation pressure to the pre-set randomized number. This insufflation pressure will be blinded on the machine from the surgeon. If the surgeon is not satisfied with the visibility, they may ask to set the pressure to 15mmHg, however, they will remain blinded. The surgeon, research team, participants and data analysts will be blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This proposed study is a single-center 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. Participants will be selected using a convenience sample from Women's College Hospital operating room list. All potentially eligible patients will be invited to participate in this study by the MIS fellow on the day of surgery up to 2 hours before the scheduled surgery. We will create a randomization list in equal ratio with study numbers 1 to 82. A member of the research team who will have no interaction with patients in this study will prepare the low and standard pressure envelopes and label them according to the randomization list.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 16, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CA (1)