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IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

NCT05608070 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-08-14

No results posted yet for this study

Summary

This double-blinded, placebo-control trial clinical trial aims to investigate the effect of IV oxytocin infusion on peri-operative opioid consumption following a minimally invasive hysterectomy under general anesthesia. The patient population will be women scheduled for an elective, minimally invasive hysterectomy at Beth Israel Deaconess Medical Center.

The investigators hypothesize that, compared to a placebo, exposure to intravenous (IV) oxytocin will reduce the amount of opioid consumption for women after a minimally invasive hysterectomy procedure.

Conditions

  • Pain, Postoperative
  • Analgesia
  • Postoperative Pain
  • Pain, Post Operative
  • Oxytocin

Interventions

DRUG

Oxytocin

Oxytocin 30 IU in 500 ml IV at a rate of 5 IU/h (83.33 ml/h). The infusion will be started intra-operative once the uterus is removed and will continue to run until completion of the medication or discharge from PACU criteria are met, whichever occurs first.

DRUG

Placebo

0.9% saline infusion at the rate of 83.3 ml/h.

Sponsors & Collaborators

Principal Investigators

  • John J. Kowalczyk, MD · Beth Israel Deaconess Medical Center

  • Shiri Savir, MD MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608070 on ClinicalTrials.gov