Pain, PostoperativePhase 1/2LAVANCT07842159
Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy
A Phase 1/2 study testing Combined Bupivacaine and Exparel and Normal Saline (NS) in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Combined Bupivacaine and Exparel and Normal Saline (NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to 15 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Combined operation or alternative approach
- inpatient overnight admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center, Houston
Houston, Texas, 77030
Asha B Bhalwal, MD, (713) 566-4605, Asha.B.Bhalwal@uth.tmc.edu
Aya Sasson Mohr, (713) 500-6412, Aya.MohrSasson@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- Combined Bupivacaine and Exparel, Normal Saline (NS)
- Keywords
- elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH), Total Laparoscopic Hysterectomy (TLH), Benign
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Bupivacaine and Exparel | Experimental | Not described Receives: Drug: Combined Bupivacaine and Exparel |
| Control | Placebo comparator | Not described Receives: Drug: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain as assessed by the visual analog scale (VAS)
Pain will be scored from 1-10 , higher number indicating more pain
Measured: 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
Measured: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of NSAIDS needed
Measured: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the amount of opioids needed
Measured: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of opioids needed
Measured: 2-week and 6- week follow up
Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon
Measured: 2-week and 6- week follow up
Change in presence of vaginal dehiscence
This will be categorically reported as a yes or no answer
Measured: 2-week and 6- week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start17 Sep 2026 (estimated)
- Primary completion17 Mar 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asha Bhalwal, The University of Texas Health Science Center, Houston
- Investigators
- Asha B Bhalwal, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842159
- Sponsor's protocol ID
- HSC-MS-26-0008
- Acronym
- LAVA
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial
- ClinicalTrials.gov ID
- NCT07842159
- Acronym / sponsor ID
- LAVA / HSC-MS-26-0008
- Conditions
- Pain, Postoperative
- Keywords
- elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH), Total Laparoscopic Hysterectomy (TLH), Benign
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 17 Mar 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Bupivacaine and Exparel | Experimental | Drug: Combined Bupivacaine and Exparel |
| Control | Placebo comparator | Drug: Normal Saline (NS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Combined operation or alternative approach
- inpatient overnight admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Bupivacaine and ExparelIn 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 | Combined Bupivacaine and Exparel |
| 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. | Drug | Control |
Primary outcome
Change in pain as assessed by the visual analog scale (VAS)
Time frame: 4-6 hours post operation, postoperative day 1, postoperative day 3
Pain will be scored from 1-10 , higher number indicating more pain
6 secondary outcomes
Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed
Time frame: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of NSAIDS needed
Time frame: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the amount of opioids needed
Time frame: 2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of opioids needed
Time frame: 2-week and 6- week follow up
Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon
Time frame: 2-week and 6- week follow up
Change in presence of vaginal dehiscence
Time frame: 2-week and 6- week follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asha B Bhalwal, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combined Bupivacaine and Exparel and Normal Saline (NS) in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asha B Bhalwal, MD ((713) 566-4605, Asha.B.Bhalwal@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as assessed by the visual analog scale (VAS) (time frame: 4-6 hours post operation, postoperative day 1, postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.