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

NCT06349772 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: FY2024-203
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

robotic surgery; sleeve gastrectomy; zynrelef; exparel

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  this will be measured using a numerical rating scale. The scale is 0-10 with 0 being no pain and 10 being the worst pain of their life

  72 hours

Secondary Outcomes (2)

• Total postoperative opioid use

  72 hours

• Proportion of total rescue medication use

  72 hours

Study Arms (2)

Patients who receive zynrelef

EXPERIMENTAL

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

Drug: Zynrelef

Patients who receive exparel

EXPERIMENTAL

those who get exparel injected at the 12mm port incision

Drug: Exparel

Interventions

Zynrelef DRUG

Zynrelef will be injected at the 12mm port site

Patients who receive zynrelef

Exparel DRUG

Exparel will be injected at the 12mm port site

Patients who receive exparel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18-65 years old
• Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
• Is able to provide written informed consent.
• Is able to adhere to the study visit schedule and complete all study assessments.

You may not qualify if:

• Positive urine drug screen prior to surgery
• History of substance abuse in the past year-by self report
• Patient with ongoing daily narcotic use at the time of surgery-by self report
• Inability to understand informed consent or read English/Spanish
• Pregnant or lactating patients
• Prisoners
• Patients with renal or hepatic failure
• Bupivacaine use within 96 hours of operation
• 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
• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

bupivacaine-meloxicam drug combination

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Tommy Wright, DO

CONTACT

8176888021; tommy.wright@ttuhsc.edu

Vinay Goyal, MD

CONTACT

vinay.goyal@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: one year
• Access Criteria: Access will be given through the EMR

Locations

US (1)