IV oxytocin to reduce pain after minimally invasive hysterectomy
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
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 |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06483659 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.