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Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05608070
Collaborator
(none)
152
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

patients population will be women who have been scheduled for an elective, minimally invasive hysterectomy at Beth Israel Deaconness Medical Center.

We 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV Oxytocin

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.
Other Names:
  • Pitocin

    		•
    Placebo Comparator: Placebo- NaCl 0.9%

    Drug: Placebo
    0.9% saline infusion at the rate of 83.3 ml/h.
    Other Names:
  • 0.9% NaCl, Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total opioids consumption [3 days]

      Average Opioid Oral Morphine Milligram Equivalent (MME) during intra-op and post-operative period

    Secondary Outcome Measures

    1. Post Operative Pain scores [1 day]

      Mean pain scores on NRS in PACU, POD0 and POD1. Total opioid use during hospitalization (average MME during hospital stay)

    2. Anxiety score [3 days]

      STAI-6 questionnaire score on

    3. Quality of Recovery Score [3 days]

      Postoperative Quality of Recovery Score: The QoR-15

    4. Pain Catastrophizing Scale [3 days]

      We are interested in the types of thoughts and feeling that you have when you are in pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • women the age of 18-65 years old undergoing elective, minimally invasive hysterectomy under general anesthesia
    Exclusion Criteria:

    • ASA 4 or greater

    • Additional surgical components including but not limited to: minor laparotomy, omentectomy, cystectomy, and lymph node dissection.

    • Allergies to any study medication: acetaminophen, ketorolac, hydromorphone, oxycodone, fentanyl, gabapentin, pregabalin.

    • Epidural/Regional anesthesia use for intra-operative or post-operative pain.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: John Kowalczyj, MD, Beth Israel Deaconess Medical Center
    • Principal Investigator: Shiri Savir, MD MPH, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT05608070
    Other Study ID Numbers:
    • 2022P000895
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Nov 8, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Oxytocin

    Study Results

    No Results Posted as of Nov 8, 2022