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RecruitingNCT06349772Updated Jul 8, 2026

Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy

An Early Phase 1 interventional study of Zynrelef and Exparel in Post Operative Pain, sponsored by Texas Tech University Health Sciences Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Texas Tech University Health Sciences Center · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post Operative Pain

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Keywords

  • robotic surgery
  • sleeve gastrectomy
  • zynrelef
  • exparel
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 130 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  4. Is able to adhere to the study visit schedule and complete all study assessments.

Exclusion criteria

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 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Patients who receive zynrelef

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

    Drug: Zynrelef

  • Experimental
    Patients who receive exparel

    those who get exparel injected at the 12mm port incision

    Drug: Exparel

Interventions

  • DrugZynrelef

    Zynrelef will be injected at the 12mm port site

  • Exparel will be injected at the 12mm port site

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 72 hours

Secondary outcomes

  1. Total postoperative opioid use

    total amount of pain medications used postoperatively converted into morphine equivalents

    Time frame: 72 hours

  2. Proportion of total rescue medication use

    the amount of times a rescue medication had to be used

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Other researchers will be involved with gathering and interpreting data

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: one year

Access criteria: Access will be given through the EMR

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Nov 2027, 36 months after the start.

Of 65 non-industry phase 1 interventional studies under Pain, Postoperative, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's planned 36 months is above that.

Counting every sponsor, half of 83 studies reached it within 16 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2024
First posted
Apr 5, 2024
StartActual
Nov 1, 2024
Primary completionEst.
Nov 1, 2027
CompletionEst.
Dec 1, 2028
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06349772
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Nov 1, 2024
Primary completion
Nov 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Jul 8, 2026

Study contacts

Tommy Wright, DO
Contact
tommy.wright@ttuhsc.edu
8176888021
Vinay Goyal, MD
Contact
vinay.goyal@ttuhsc.edu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Liposomal Bupivacaine

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