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

NCT ID: NCT06349772

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients who receive zynrelef

Those who get zynrelef injected at the at the 12mm port incision

Group Type: EXPERIMENTAL

Zynrelef

Intervention Type: DRUG

Zynrelef will be injected at the 12mm port site

Patients who receive exparel

those who get exparel injected at the 12mm port incision

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Exparel will be injected at the 12mm port site

Interventions

Zynrelef

Zynrelef will be injected at the 12mm port site

Intervention Type: DRUG

Exparel

Exparel will be injected at the 12mm port site

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tommy Wright, DO

Role: CONTACT

tommy.wright@ttuhsc.edu

8176888021

Vinay Goyal, MD

Role: CONTACT

vinay.goyal@ttuhsc.edu

Facility Contacts

Chad Copeland

Role: primary

CHADLEY.COPELAND@TTUHSC.EDU

806-743-6239

Other Identifiers

FY2024-203

Identifier Type: -

Identifier Source: org_study_id