Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

NCT06719180 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2172359
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Milligrams of Morphine Equivalent Used

  From enrollment to end of treatment at 4 hours.

Secondary Outcomes (2)

• Counts of Non-Opioid Analgesics Used

  From enrollment to end of treatment at 4 hours.

• Patient Change in Pain Score (0-10)

  From Baseline to end of treatment at 4 hours

Study Arms (2)

Vaginal Cuff Anesthesia

EXPERIMENTAL

Drug: Bupivacain

Vaginal Cuff Saline

PLACEBO COMPARATOR

Other: Saline (NaCl 0,9 %) (placebo)

Interventions

Bupivacain 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 Anesthesia

Saline (NaCl 0,9 %) (placebo) OTHER

A saline placebo

Vaginal Cuff Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MediSys Health Network: lead

Study Sites (1)

Flushing Hospital Medical Center

Flushing, New York, 11355, United States

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Hosam Hanna, MD

CONTACT

(718) 670-5571; hhanna@jhmc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

US (1)