Status:
RECRUITING
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 fol...
Detailed 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...
Eligibility Criteria
Inclusion
- Ages 18-65 years old
- ASA category 1-3
- Scheduled to undergo minimally invasive hysterectomy
- No documented allergy to oxytocin
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06483659
Start Date
June 1 2025
End Date
December 1 2026
Last Update
December 30 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215