RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06349772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age range: 18-65 years old
  2. 2. Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
  3. 3. Is able to provide written informed consent.
  4. 4. Is able to adhere to the study visit schedule and complete all study assessments.
  1. 1. Positive urine drug screen prior to surgery
  2. 2. History of substance abuse in the past year-by self report
  3. 3. Patient with ongoing daily narcotic use at the time of surgery-by self report
  4. 4. Inability to understand informed consent or read English/Spanish
  5. 5. Pregnant or lactating patients
  6. 6. Prisoners
  7. 7. Patients with renal or hepatic failure
  8. 8. Bupivacaine use within 96 hours of operation
  9. 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. 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

Contacts and Locations

Study Contact

Tommy Wright, DO
CONTACT
8176888021
tommy.wright@ttuhsc.edu
Vinay Goyal, MD
CONTACT
vinay.goyal@ttuhsc.edu

Study Locations (Sites)

Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
United States

Collaborators and Investigators

Sponsor: Texas Tech University Health Sciences Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • robotic surgery
  • sleeve gastrectomy
  • zynrelef
  • exparel

Additional Relevant MeSH Terms

  • Post Operative Pain