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

MediSys Health Network1 site in 1 country100 target enrollmentDecember 1, 2024

ConditionsHysterectomy Post Operative Analgesia

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

DrugsBupivacain

Overview

Phase: Phase 4
Intervention: Bupivacain
Conditions: Hysterectomy
Sponsor: MediSys Health Network
Enrollment: 100
Locations: 1
Primary Endpoint: Milligrams of Morphine Equivalent Used
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

October 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

MediSys Health Network

Responsible Party

Sponsor

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)

Arms & Interventions

Vaginal Cuff Anesthesia

Intervention: Bupivacain

Vaginal Cuff Saline

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

Outcomes

Primary Outcomes

Milligrams of Morphine Equivalent Used

Time Frame: From enrollment to end of treatment at 4 hours.

Secondary Outcomes

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)