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

Launched by TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two pain relief options for patients undergoing robotic sleeve gastrectomy, a type of weight-loss surgery. The study is looking at Zynrelef, which is a combination of two medications, bupivacaine and meloxicam, versus Exparel, which is a type of long-lasting local anesthesia. The goal is to see which medication provides better pain control after surgery, both in the hospital and at home, by evaluating pain scores and total use of opioid medications over the first 72 hours after the operation.

To participate in the trial, candidates must be between 18 and 65 years old and scheduled for the surgery with Dr. Goyal. They should be able to understand the study details and agree to participate. However, there are certain criteria that would exclude someone from joining, such as recent substance abuse or certain health conditions. Participants will receive one of the two medications during their surgery and will be monitored to assess how well it helps manage their pain afterward. This study is important as it aims to find the most effective way to manage postoperative pain, which can significantly affect recovery.

Gender

ALL

Eligibility 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