Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

NCT ID: NCT06719180

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vaginal Cuff Anesthesia

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: DRUG

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

Vaginal Cuff Saline

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: OTHER

A saline placebo

Interventions

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

Intervention Type: DRUG

Saline (NaCl 0,9 %) (placebo)

A saline placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
• Presence of malignancy

Exclusion Criteria

• Conversion to laparotomy

• Previous multiple abdominal and/or pelvic surgeries
• Significant medical comorbidities or cardiac history
• Poor initial Aldrete score4 (<10)
• Significant pre-op pain medication use
• Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MediSys Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Flushing Hospital Medical Center

Flushing, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hosam Hanna, MD

Role: CONTACT

hhanna@jhmc.org

(718) 670-5571

Facility Contacts

Hosam Hanna, MD

Role: primary

hhanna@jhmc.org

(718) 670-5571

Other Identifiers

2172359

Identifier Type: -

Identifier Source: org_study_id