IV oxytocin to reduce pain after minimally invasive hysterectomy
Official title: Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Run by Brigham and Women's Hospital · NCT06483659 · Data updated 2026-11-12
This trial will try an IV oxytocin infusion versus placebo to see if it lowers opioid use and pain in women having minimally invasive hysterectomy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 152 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06483659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–65 with ASA physical status 1–3 who are scheduled for an elective minimally invasive hysterectomy and have no allergy to oxytocin and are not taking high-dose opioids or medications for opioid use disorder.
✕Probably not a fit
Patients older than 65, ASA class 4 or higher, those undergoing additional major procedures or conversion to open surgery, those on >10 mg oxycodone/day or with opioid use disorder, or those receiving regional/epidural anesthesia are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blinded, placebo-controlled Phase 2 trial enrolling 152 women undergoing elective minimally invasive hysterectomy under general anesthesia. Participants are randomized 1:1 to receive either an oxytocin infusion (30 IU in 500 mL at 5 IU/hour, ~83.3 mL/hour) or identical-appearing 0.9% saline, with patients, clinicians, and raters blinded to assignment. The primary focus is peri-operative opioid consumption and post-operative pain reduction, with the investigational pharmacy handling randomization and drug preparation. Screening, consent, and some pre-operative interactions may be remote, but infusion and surgical care occur at the hospital.
Why it matters
Potential benefit: If successful, the approach could reduce perioperative opioid requirements and lessen post-hysterectomy pain for eligible patients.
How similar studies have gone: Preclinical work and small clinical reports suggest oxytocin can modulate pain, but IV perioperative oxytocin for hysterectomy has limited prior evidence and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: John J. Kowalczyk, MD
- Email: jkowalczyk@bwh.harvard.edu
- Phone: 617-732-8220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.