Recruiting
Phase 2

Oxytocin

Sponsor:

Brigham and Women's Hospital

Code:

NCT06483659

Conditions

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Oxytocin

Placebo

Study Details

Brief 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.

Conditions

Postoperative Pain

Study ID

NCT06483659

Start date

Jun 1, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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)
  • Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone.
  • Epidural/Regional anesthesia for intra-operative or post-operative pain.
  • Inability to understand the questionnaires
  • Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL >500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medication

one group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline .

placebo comparator: Placebo

one group will receive 500 ml of 0.9% normal saline

Interventions

Oxytocin

Intravenous Oxytocin infusion

Placebo

0.9% Saline

Primary outcome measure

  • Post-operative pain [ Time Frame: Between 2-4 hours after surgery completion (in the PACU) ]

Central Contacts and Locations

Central contacts

John J. Kowalczyk, MD

617-732-8220jkowalczyk@bwh.harvard.edu

Rusul I Al-Ani

617-525-6483rual-ani@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-13.