Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy (LAVA)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Combined Bupivacaine and Exparel; Drug: Normal Saline (NS)

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Asha B Bhalwal, MD; Phone Number: (713) 566-4605; Email: Asha.B.Bhalwal@uth.tmc.edu
• Study Contact Backup: Name: Aya Sasson Mohr; Phone Number: (713) 500-6412; Email: Aya.MohrSasson@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center, Houston
      • Contact: Asha B Bhalwal, MD; Phone Number: (713) 566-4605; Email: Asha.B.Bhalwal@uth.tmc.edu
      • Contact: Aya Sasson Mohr; Phone Number: (713) 500-6412; Email: Aya.MohrSasson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	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.
Experimental: Combined Bupivacaine and Exparel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as assessed by the visual analog scale (VAS)	Pain will be scored from 1-10 , higher number indicating more pain	4-6 hours post operation, postoperative day 1, postoperative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of NSAIDS needed		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the amount of opioids needed		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of opioids needed		2-week and 6- week follow up
Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon		2-week and 6- week follow up
Change in presence of vaginal dehiscence	This will be categorically reported as a yes or no answer	2-week and 6- week follow up

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Asha B Bhalwal, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): September 17, 2026
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): September 15, 2028

Study Registration Dates

• First Submitted: September 20, 2026
• First Submitted That Met QC Criteria: September 20, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): September 25, 2026
• Last Update Submitted That Met QC Criteria: September 20, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Benign; elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH); Total Laparoscopic Hysterectomy (TLH)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: HSC-MS-26-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No