Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID06719180

Study of Vaginal Cuff Anesthesia with Bupivacaine Injection and Its Effect on Post-Operative Pain Medication Use after Hysterectomy A Randomized Controlled Trial

Led by MediSys Health Network · Updated on 2025-01-07

100

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out if injecting a local anesthetic called Bupivacaine with epinephrine into the vaginal cuff before closing it after a total laparoscopic hysterectomy can reduce immediate postoperative pain medication use and improve patient comfort and satisfaction. The study focuses on women 18 years and older undergoing hysterectomy for benign conditions, excluding those with malignancy or other factors that may affect outcomes. It is a Phase 4 randomized controlled trial evaluating pain management after surgery. Participants will receive an injection either of Bupivacaine with epinephrine or a saline placebo into four points around the vaginal cuff before it is closed with a suture. Each injection point will be 1 cm from the edges of the cuff, reaching a depth of 3-4 cm, with 5 cc of the assigned solution injected at each site. This procedure is performed during the surgical operation just before vaginal cuff closure. During the study, researchers will monitor the total amount of morphine-equivalent pain medication used by participants from enrollment until 4 hours after treatment. This will help assess pain control effectiveness. Participants’ comfort and satisfaction levels will also be evaluated. The study involves follow-up during the immediate postoperative period to ensure safety and collect outcome data.

CONDITIONS

Official Title

Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
  • Presence of malignancy
Not Eligible

You will not qualify if you...

  • Conversion to laparotomy
  • Previous multiple abdominal and/or pelvic surgeries
  • Significant medical comorbidities or cardiac history
  • Poor initial Aldrete score less than 10
  • Significant preoperative pain medication use
  • Contraindication to any medication used in the study (Bupivacaine, epinephrine, tramadol, or oxycodone)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Flushing Hospital Medical Center

Flushing, New York, United States, 11355

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Research Team

H

Hosam Hanna, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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