Actively Recruiting
A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Led by MediSys Health Network · Updated on 2025-01-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether injecting a local anesthetic called Bupivacaine with epinephrine into the vaginal cuff before closure during total laparoscopic hysterectomy can reduce the need for immediate postoperative pain medication and improve patient comfort and satisfaction. This randomized, quadruple-masked study focuses on women aged 18 and older undergoing hysterectomy for benign conditions. Participants receive either an injection of Bupivacaine with epinephrine or a saline placebo at four points around the vaginal cuff before closure using a sterilized needle. Each injection delivers 5cc of the assigned solution to a depth of 3-4 cm. The study compares postoperative pain medication use and patient-reported pain scores within the first four hours after surgery. During the study, researchers measure the amount of opioid pain medication (in morphine equivalents) and non-opioid analgesics used, along with changes in patients' pain scores from baseline to four hours after treatment. Monitoring includes assessing patient comfort and medication use immediately following surgery. Participation involves a single surgical procedure with postoperative follow-up lasting four hours for outcome measurement.
CONDITIONS
Brief 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
You will not qualify if you...
- Presence of malignancy
- Conversion to laparotomy
- Previous multiple abdominal and/or pelvic surgeries
- Significant medical comorbidities or cardiac history
- Poor initial Aldrete score less than 10
- Significant pre-op pain medication use
- Contraindication to any medication used in the study (Bupivacaine, epinephrine, tramadol, or oxycodone)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 hours following surgery
Participants undergo a total laparoscopic hysterectomy and receive an injection of either bupivacaine or saline placebo into the vaginal cuff before closure to manage post-operative pain.
1 surgical procedure visit
Duration - Up to 4 hours after treatment
Participants are monitored for pain medication use and pain scores after surgery.
Assessments during recovery period
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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