ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy (HeronBariatric) PUBLISHED

  • STATUS
    Recruiting
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Updated on 12 May 2025

Summary

Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio:
Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge.
Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge.
Primary Objective:
To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy.
Secondary Objectives:
  1. To evaluate additional efficacy parameters, including opioid load, in this study population.
  2. To determine the impact of ZYNRELEF® on the cost of pain management.
  3. To assess the time taken to resume exercise after discharge.
  4. To assess the adverse events reported following the use of ZYNRELEF®.

Description


Details
Condition Atopic Dermatitis, Post Operative Pain, Acute, Bariatric Surgery Candidate, Postoperative Pain
Age 18years - 100years
Clinical Study IdentifierTX13143
Last Modified on12 May 2025

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