Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Brigham and Women's Hospital
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.
Description
152 women will be randomized into one of two arms; participants in the first arm (Intervention) will receive oxytocin infusion, 30 IU in 500 ml IV infusion at a rate of 5 IU/h (83.33 ml/h), the second arm (Control) will receive 0.9% normal saline 500 ml IV infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm. The investigational research pharmacy will perform randomization; participants will be randomized in a 1:1 ratio to receive either Oxytocin or Placebo (0.9% normal sali…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Ages 18-65 years old * ASA category 1-3 * Scheduled to undergo minimally invasive hysterectomy * No documented allergy to oxytocin Exclusion Criteria: * American Society of Anesthesiologists (ASA) group 4 or greater * Age \>65 years old * Additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and/or ablation of endometriosis. * Active opioid prescription of the equivalent of oxycodone \>10 mg /day * Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone)…
Interventions
- DrugOxytocin
Intravenous Oxytocin infusion
- DrugPlacebo
0.9% Saline
Location
- Brigham and Women's HospitalBoston, Massachusetts