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Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

NCT06504277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-07-31

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

Low Pressure Penumoperitoneum

Maintained Pneumoperitoneum with low pressure of 10 mm Hg

OTHER

Standard Pressure Group (No intervention- active comparator)

Maintained Pneumoperitoneum at standard pressure of 15 mm Hg

Sponsors & Collaborators

  • Women's College Hospital

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2026-07-10
Completion
2026-09-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504277 on ClinicalTrials.gov