Comparing two pain control methods after robotic sleeve gastrectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Zynrelef, a combination of bupivacaine and meloxicam, versus Exparel, an injectable liposomal bupivacaine, for managing postoperative pain following robotic sleeve gastrectomy. Participants will be randomly assigned to receive either Zynrelef or Exparel at the closure site of their surgery. The study will assess pain levels using a numerical rating scale for up to 72 hours post-surgery, along with tracking total opioid use. The goal is to determine which method provides better pain control and to analyze the associated costs of the medications used.

Why it matters

Who can join: the full rules

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

Where it's running

• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting

Study contacts

• Study coordinator: Tommy Wright, DO
• Email: tommy.wright@ttuhsc.edu
• Phone: 8176888021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.