Recruiting
Early Phase 1

Zynrelef vs. Exparel

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT06349772

Conditions

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Zynrelef

Exparel

Study Details

Brief 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. 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

Study ID

NCT06349772

Start date

Nov 1, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age range: 18-65 years old
2. Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
3. Is able to provide written informed consent.
4. Is able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

1. Positive urine drug screen prior to surgery
2. History of substance abuse in the past year-by self report
3. Patient with ongoing daily narcotic use at the time of surgery-by self report
4. Inability to understand informed consent or read English/Spanish
5. Pregnant or lactating patients
6. Prisoners
7. Patients with renal or hepatic failure
8. Bupivacaine use within 96 hours of operation
9. 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
10. 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients who receive zynrelef

Those who get zynrelef injected at the at the 12mm port incision

experimental: Patients who receive exparel

those who get exparel injected at the 12mm port incision

Interventions

Zynrelef

Zynrelef will be injected at the 12mm port site

Exparel

Exparel will be injected at the 12mm port site

Primary outcome measure

  • postoperative pain score [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Tommy Wright, DO

8176888021tommy.wright@ttuhsc.edu

Vinay Goyal, MD

vinay.goyal@ttuhsc.edu

Locations

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Chad Copeland

806-743-6239CHADLEY.COPELAND@TTUHSC.EDU

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • robotic surgery
  • sleeve gastrectomy
  • zynrelef
  • exparel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-07-08.