The LOw PRESSuRE Trial: Laparoscopic Optimization With Pressure Reduction
NCT Number: NCT06504277
Acronym: LOw PRESSuRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery|Laparoscopic|Laparoscopy|Penumoperitoneum|Post-operative Pain|Post-operative Recovery
Interventions: PROCEDURE: Low Pressure Penumoperitoneum|OTHER: Standard Pressure Group (No intervention- active comparator)
Sponsor: Mount Sinai Hospital, Canada
Collaborators: Women's College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-09-15

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 the to standard group or the intervention group (low pressure) and surgeons will be blinded to study pressure. Data on post operative recovery and pain scores will be recorded for each group.

Primary Outcome Measures: 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 for pain, NRS (numeric rating score) scores on a scale from 0-10 (the higher the score the worse the pain), 1 day post op
Secondary Outcome Measures: Shoulder tip pain (short term), NRS (numeric rating score) scores for shoulder-tip pain at 1 and 2 hours on a scale from 0-10 (the higher the score the worse the pain), 1 and 2 hours|Quality of recovery (QoR) score, QoR (Quality of recovery) score on Post operative day 1 a prevalidated score out of 150, and the higher the score the better the recovery, post operative day 1|Generalized Pain score self reported rating, generalized pain at 1 and 2 hours and on POD1, self reported pain score on a scale 0-10, with the higher the score the worse the pain, 1, 2 hours post op and post op day 1|Incidence of Nausea and Vomitting, documented incidence (yes or no) of nausea, vomiting, and bloating at 1 and 2 hours and on POD1. incidence/presence of nausea and vomiting is worse, 1, 2 hours post op and post op day 1|Narcotic use, narcotic consumption measured as total dose of narcotics in PACU and between discharge and the POD1 phone call, 1 day post operative|surgical time, duration of surgery, duration of surgery (day surgery)|estimated blood loss, estimated blood loss, duration of surgery (day surgery)|Adverse Effect/Complications, adverse effects/complication rates in hospital and reported by the POD1 phone call, 1 day post operative|Surgeon visibility, surgeon visibility rating, visibility during surgery assessed by surgeon rating on a 5-point Likert scale. greater score means greater visibility (better), duration of surgery|anesthetist satisfaction, anesthetist satisfaction rating, measured by anaesthetist satisfaction with ventilation during surgery as assessed by anaesthetist rating on a 5-point Likert scale (higher score is better), duration of surgery