NCT06483659 Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
| NCT ID | NCT06483659 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 152 participants in total. It began in 2025-06-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06483659 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06483659 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06483659 currently recruiting?
Yes, NCT06483659 is actively recruiting participants. Contact the research team at jkowalczyk@bwh.harvard.edu for enrollment information.
Where is the NCT06483659 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06483659 clinical trial?
NCT06483659 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 152 participants.