Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy

NCT07842159 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HSC-MS-26-0008
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH); Total Laparoscopic Hysterectomy (TLH); Benign

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Combined Bupivacaine and Exparel

EXPERIMENTAL

Drug: Combined Bupivacaine and Exparel

Control

PLACEBO COMPARATOR

Drug: Normal Saline (NS)

Interventions

Combined Bupivacaine and Exparel DRUG

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.

Combined Bupivacaine and Exparel

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.

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Combined operation or alternative approach
• inpatient overnight admission

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Asha B Bhalwal, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asha B Bhalwal, MD

CONTACT

(713) 566-4605; Asha.B.Bhalwal@uth.tmc.edu

Aya Sasson Mohr

CONTACT

(713) 500-6412; Aya.MohrSasson@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Non-Tenure Clinical

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)