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

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University Health Sciences Center
Study ID
NCT06349772
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Zynrelef — DRUG
    Zynrelef will be injected at the 12mm port site
  • Exparel — DRUG
    Exparel will be injected at the 12mm port site

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Mar 2025
Primary completion
Nov 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients who receive zynrelef
    Those who get zynrelef injected at the at the 12mm port incision
  • Experimental: Patients who receive exparel
    those who get exparel injected at the 12mm port incision

Primary Outcome Measure

postoperative pain score [ Time Frame: 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech University Health Sciences CenterLubbockTexas79430
Chad Copeland
[email protected]
806-743-6239

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By research site
Texas Tech University Health Sciences Center· Lubbock, TX

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