Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy

Phase 2Not Yet RecruitingNCT07842159

The University of Texas Health Science Center, Houston104 enrolled

Overview

The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Pain, Postoperative

Interventions

Combined Bupivacaine and ExparelDRUG

In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.

Normal Saline (NS)DRUG

In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least 66.5kg weight * elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights. Exclusion Criteria: * Combined operation or alternative approach * inpatient overnight admission

Locations (1)

The University of Texas Health Science Center, Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in pain as assessed by the visual analog scale (VAS)

Pain will be scored from 1-10 , higher number indicating more pain

Time frame: 4-6 hours post operation, postoperative day 1, postoperative day 3

Secondary Outcomes

Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed