Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
NCT Number: NCT06483659
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Pain
Interventions: DRUG: Oxytocin|DRUG: Placebo
Sponsor: Brigham and Women's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2025-12-01

Summary:
This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.

Primary Outcome Measures: Post-operative pain, Assess the impact of a perioperative infusion of oxytocin on postoperative pain, the average patient pain scores measured as a mean Brief Pain Inventory in PACU after laparoscopic hysterectomy in treated and untreated groups will be compared, Between 2-4 hours after surgery completion (in the PACU)
Secondary Outcome Measures: Perioperative opioid consumption, Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs), From start of infusion until approximately 6 hour mark (infusion completion)|POD1 Opioid consumption, Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs), In the first 24 hours after surgery|POD2 Opioid consumption, Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs), From 24-48 hours after surgery|POD3 Opioid consumption, Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs), From 48-72 hours after surgery|PACU satisfaction scores, Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups, Between 2-4 hours after surgery completion (in the PACU)|POD1 satisfaction scores, Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups, On Post-operative day 1|POD2 satisfaction scores, Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups, On Post-operative day 2|POD3 satisfaction scores, Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale between groups, On Post-operative day 3|PACU Post-operative pain, Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) in PACU after laparoscopic hysterectomy in treated and untreated groups, Between 2-4 hours after surgery completion (in the PACU)|POD1 Post-operative pain, Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD1 in treated and untreated groups, On Post-operative day 1|POD2 Post-operative pain, Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD2 in treated and untreated groups, On Post-operative day 2|POD3 Post-operative pain, Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD3 in treated and untreated groups, On Post-operative day 3|Intraoperative hypotension (# of episodes of MAP <60 mmHg), Assess the impact of a perioperative infusion of oxytocin on hypotension, Through surgery completion, an average of 2 hours (From start of infusion to completion end of time in the operating room)|PACU hypotension (# of episodes of MAP <60 mmHg), Assess the impact of a perioperative infusion of oxytocin on hypotension, Between 0-4 hours after surgery completion (in the PACU)