Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06349772

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

Led by Texas Tech University Health Sciences Center · Updated on 2025-03-21

130

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years old
  • Scheduled or planned to have robotic sleeve gastrectomy by Dr. Goyal
  • Able to provide written informed consent
  • Able to follow study visit schedule and complete all assessments
Not Eligible

You will not qualify if you...

  • Positive urine drug screen before surgery
  • History of substance abuse in the past year by self-report
  • Daily narcotic use at the time of surgery by self-report
  • Unable to understand informed consent or read English/Spanish
  • Pregnant or lactating patients
  • Prisoners
  • Patients with kidney or liver failure
  • Use of bupivacaine within 96 hours before surgery
  • Intolerance or contraindication to opiates, nonsteroidal anti-inflammatory drugs, acetaminophen, Zynrelef, or Exparel
  • History of asthma, urticaria, or allergic reactions to aspirin or NSAIDs, including severe anaphylaxis

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Trial Site Locations

Total: 1 location

1

Texas Tech University Health Sciences Center

Lubbock, Texas, United States, 79430

Actively Recruiting

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Research Team

T

Tommy Wright, DO

CONTACT

V

Vinay Goyal, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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