NCT06349772 Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
| NCT ID | NCT06349772 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Texas Tech University Health Sciences Center |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2024-11-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06349772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06349772 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06349772 currently recruiting?
Yes, NCT06349772 is actively recruiting participants. Contact the research team at tommy.wright@ttuhsc.edu for enrollment information.
Where is the NCT06349772 trial being conducted?
This trial is being conducted at Lubbock, United States.
Who is sponsoring the NCT06349772 clinical trial?
NCT06349772 is sponsored by Texas Tech University Health Sciences Center. The trial plans to enroll 130 participants.