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NOT YET RECRUITING
NCT07842159
PHASE1/PHASE2

Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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.

Official title: Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-09-17

Completion Date

2028-09-15

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

Combined Bupivacaine and Exparel

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.

DRUG

Normal Saline (NS)

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.

Locations (1)

The University of Texas Health Science Center, Houston

Houston, Texas, United States