Comparing two pain control methods after robotic sleeve gastrectomy
Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
This study is testing whether a new pain control method called Zynrelef works better than Exparel for managing pain after robotic sleeve gastrectomy surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 1 site (Lubbock, Texas) |
| Trial ID | NCT06349772 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 scheduled for robotic sleeve gastrectomy who can provide informed consent.
Not a fit: Patients with a history of substance abuse, ongoing narcotic use, or contraindications to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management strategies for patients undergoing robotic sleeve gastrectomy.
How similar studies have performed: Previous studies have shown promise in using extended local anesthesia for postoperative pain control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lubbock, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.