Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

NCT06719180 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Hysterectomy
  • Post Operative Analgesia

Interventions

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

OTHER

Saline (NaCl 0,9 %) (placebo)

A saline placebo

Sponsors & Collaborators

  • MediSys Health Network

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06719180 on ClinicalTrials.gov