Low vs Standard Pressure for Postoperative Pain
(LOw PRESSuRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for individuals undergoing certain benign gynecologic surgeries, such as removal of ovaries or ovarian cysts. Participants must understand and sign the consent form, be able to follow study procedures, and have the capacity to provide informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic gynecologic surgery with either low or standard pressure pneumoperitoneum
Post-operative Monitoring
Post-operative pain, nausea, and medication use are assessed in the PACU. Patients are contacted on POD1 to assess post-operative pain scores and adverse events.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pain and recovery scores
What Are the Treatments Tested in This Trial?
Interventions
- Low Pressure Pneumoperitoneum
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
Women's College Hospital
Collaborator