NCT06719180

Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MediSys Health Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2024-12-05
• Last updated: 2025-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study