Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

January 6, 2025 updated by: MediSys Health Network

A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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.

Study Contact

  • Name: Hosam Hanna, MD
  • Phone Number: (718) 670-5571
  • Email: hhanna@jhmc.org

Study Locations

  • United States
    • New York
      • Flushing, New York, United States, 11355
        • Recruiting
        • Flushing Hospital Medical Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
  • Presence of malignancy

Exclusion Criteria:

  • Conversion to laparotomy

    • Previous multiple abdominal and/or pelvic surgeries
    • Significant medical comorbidities or cardiac history
    • Poor initial Aldrete score4 (<10)
    • Significant pre-op pain medication use
    • Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)

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: Vaginal Cuff Anesthesia
Drug: Bupivacain
Injection into the vaginal cuff will occur before vaginal cuff closure with stratafix suture. There will be four points of injection 1cm from the edges of the vaginal cuff with a sterilized needle to a depth of 3-4cm. 5cc of bupivacaine with epinephrine or 5cc of normal saline will be injected into each area
Placebo Comparator: Vaginal Cuff Saline
Other: Saline (NaCl 0,9 %) (placebo)
A saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Milligrams of Morphine Equivalent Used
Time Frame: From enrollment to end of treatment at 4 hours.
From enrollment to end of treatment at 4 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Counts of Non-Opioid Analgesics Used
Time Frame: From enrollment to end of treatment at 4 hours.
From enrollment to end of treatment at 4 hours.
Patient Change in Pain Score (0-10)
Time Frame: From Baseline to end of treatment at 4 hours
Change in value of pain score, measured on a 0-10 scale.
From Baseline to end of treatment at 4 hours

Collaborators and Investigators

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

Sponsor

MediSys Health Network

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)

December 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2172359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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