Actively Recruiting
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
Eligibility Criteria
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
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
Actively Recruiting
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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