Post Operative PainEarly Phase 1NCT06349772
Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
A Early Phase 1 study testing Zynrelef and Exparel in people with Post Operative Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Zynrelef and Exparel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Dec 2028
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years old
- Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
Who cannot join
- Positive urine drug screen prior to surgery
- History of substance abuse in the past year-by self report
- Patient with ongoing daily narcotic use at the time of surgery-by self report
- Inability to understand informed consent or read English/Spanish
- Pregnant or lactating patients
- Prisoners
Show all 10Show fewer
- Patients with renal or hepatic failure
- Bupivacaine use within 96 hours of operation
- Patient intolerant of opiates, nonsteroidal anti-inflammatory drug s, acetaminophen, or Zynrelef and Exparel. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs
- Patient with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vinay Goyal, MD contact
United States1 site, 1 recruiting
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Chad Copeland, 806-743-6239, CHADLEY.COPELAND@TTUHSC.EDU
About this study
The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.
- Conditions
- Post Operative Pain
- Being tested
- Zynrelef, Exparel
- Keywords
- robotic surgery, sleeve gastrectomy, zynrelef, exparel
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZynrelefDrug
Zynrelef will be injected at the 12mm port site
ExparelDrug
Exparel will be injected at the 12mm port site
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive zynrelef | Experimental | Those who get zynrelef injected at the at the 12mm port incision Receives: Drug: Zynrelef |
| Patients who receive exparel | Experimental | those who get exparel injected at the 12mm port incision Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
this will be measured using a numerical rating scale. The scale is 0-10 with 0 being no pain and 10 being the worst pain of their life
Measured: 72 hours
Secondary outcomes (2)
Total postoperative opioid use
total amount of pain medications used postoperatively converted into morphine equivalents
Measured: 72 hours
Proportion of total rescue medication use
the amount of times a rescue medication had to be used
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349772
- Sponsor's protocol ID
- FY2024-203
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers will be involved with gathering and interpreting data
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06349772
- Acronym / sponsor ID
- FY2024-203
- Conditions
- Post Operative Pain
- Keywords
- robotic surgery, sleeve gastrectomy, zynrelef, exparel
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 5 Apr 2024 (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 evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively
| Arm | Type | Receives |
|---|---|---|
| Patients who receive zynrelef | Experimental | Drug: ZynrelefThose who get zynrelef injected at the at the 12mm port incision |
| Patients who receive exparel | Experimental | Drug: Exparelthose who get exparel injected at the 12mm port incision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 18-65 years old
- Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
Key exclusion criteria (10 listed)
- Positive urine drug screen prior to surgery
- History of substance abuse in the past year-by self report
- Patient with ongoing daily narcotic use at the time of surgery-by self report
- Inability to understand informed consent or read English/Spanish
- Pregnant or lactating patients
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 |
|---|---|---|
| ZynrelefZynrelef will be injected at the 12mm port site | Drug | Patients who receive zynrelef |
| ExparelExparel will be injected at the 12mm port site | Drug | Patients who receive exparel |
Primary outcome
postoperative pain score
Time frame: 72 hours
this will be measured using a numerical rating scale. The scale is 0-10 with 0 being no pain and 10 being the worst pain of their life
2 secondary outcomes
Total postoperative opioid use
Time frame: 72 hours
Proportion of total rescue medication use
Time frame: 72 hours
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Other researchers will be involved with gathering and interpreting data
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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.
Vinay Goyal, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zynrelef and Exparel in people with Post Operative Pain, run by Texas Tech University Health Sciences Center 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Tommy Wright, DO (8176888021, tommy.wright@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: 72 hours). 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 8 Jul 2026.