IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

August 10, 2023 updated by: Lauren Peter, Beth Israel Deaconess Medical Center

Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy: A Randomized Placebo-Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  • Patients will be recruited for participation in this study while they are in pre-operative holding area before surgery.
  • Once the patient is recruited and consented the patient, they will be randomized for either the intervention group (IV oxytocin) or control group (0.9% normal saline).
  • In the holding area, a pre-operative pain questionnaire, including the State-Trait Anxiety Inventory (STAI-6) questionnaire and the Daily Pain Catastrophizing Scale (DPCS), will be performed.
  • The STAI-6 is a validated, short 6-question form to assess anxiety. It is one of the most frequently used measures of anxiety in applied psychology research and has been used to assess anxiety in perioperative patients and to assess the potential of a patient to have higher postoperative pain and opioid requirements and a greater likelihood to use chronic opioids or develop chronic pain.
  • The DPCS is a validated, short questionnaire to assess measure of catastrophizing in the context of actual or anticipated pain. Similar to the STAI-6, it has been shown to predict patients who experience higher postoperative pain and opioid requirements and those with a greater likelihood of using chronic opioids or developing chronic pain.
  • Both groups (intervention and control) will be treated pre-operatively with acetaminophen 1000 mg and gabapentin 300 mg orally.
  • The Investigational Research Pharmacy will be informed and prepare medication or placebo.
  • The primary anesthesiology team receive either the study medication or placebo in 500 ml bag of labeled as "Oxytocin Study Drug for IV infusion".
  • A recommended "Intra-Operative Analgesia Management" algorithm will be given to the primary anesthetic team. The recommended algorithm for intra-operative analgesia management will include the following recommendation:
  • Fentanyl 100 mcg IV for induction.
  • Dexamethasone 8 mg IV after induction but prior to incision.
  • Small, titrated doses of Hydromorphone IV boluses (0.2-0.4 mg) during the operation and before emergence according to primary team judgment.
  • Ketorolac 30 mg IV at skin closure unless otherwise contraindicated.
  • 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 aspects of each patient's routine clinical care will continue as per the attending physician under whom the patient is admitted, regardless of treatment arm status.
  • The intervention group will be treated with oxytocin 30 IU in 500 ml IV at a rate of 5 IU/h (83.33 ml/h). The control group will be given IV 0.9% saline infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery and nurses), research team and the patient will all be blinded for the treatment.
  • In the PACU, a brief postoperative pain questionnaire will be done, including the Surgical Pain Scales (SPS).
  • The SPS is a validated scale that consists of 4 items that measure pain at rest, during normal activities, during work/exercise and quantify the unpleasantness of worst pain. This scale has been validated in a number of different types of postoperative pain, including women after gynecologic surgery.
  • Vital signs, NRS pain scores and opioid consumption at PACU will be collected from the patient's medical record.
  • Patients whose surgery was converted to open, EBL >500 ml or any other surgical complication that necessitates a hospitalization will be excluded from the trial.
  • For secondary outcomes, including total opioid consumption in 24, 48, and 72 hours and pain scores at POD1, 2, and 3, an online survey will be done at POD1, 2, and 3. For patients who do not complete the survey, a phone call from a study staff member will be performed to complete all questions not completed with the online form.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women the age of 18-65 years old undergoing elective, minimally invasive hysterectomy under general anesthesia

Exclusion Criteria:

  • American Society of Anesthesiology (ASA) Physical Status Classification System Score of 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 used for intra-operative or post-operative pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioids consumption
Time Frame: 3 days
Average Opioid Oral Morphine Milligram Equivalent (MME) during intra-operative and post-operative period
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Pain scores
Time Frame: 2 days
11-point (0-10) pain scores on Numerical Rating Scale (NRS) in Post Anesthesia Care Unit (PACU), Post-Operative Day (POD) 0 and POD1.
2 days
Anxiety score
Time Frame: 3 days
State-Trait Anxiety Inventory (STAI-6)
3 days
Quality of Recovery Score
Time Frame: 3 days
Postoperative Quality of Recovery Score (QoR-15)
3 days
Catastrophizing Scale
Time Frame: 3 days
Daily Pain Catastrophizing Scale (DPCS)
3 days
Patient-rated Satisfaction
Time Frame: 1 day
11-point (0-10) patient satisfaction scores on Numerical Rating Scale (NRS) in PACU and POD0
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: John J. Kowalczyk, MD, Beth Israel Deaconess Medical Center
  • Study Director: Shiri Savir, MD MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P000895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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