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ZYNRELEF for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
NCT05863221Phase 4
Key facts
- Status
- Unknown
- Start
- May 2023
- Primary completion
- Oct 2024
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, open-label trial of bupivacaine + meloxicam in postoperative pain (2 arms). Primary endpoints: Postoperative Pain Scores at 28 days, Opioid rescue medication use at 28 days and 5 more. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Zynrelef + SOC
ZYNRELEF instillation + Ropivacaine + Dexamethasone + Acetaminophen
SOC
Ropivacaine + Dexamethasone + Acetaminophen
03
Who it enrols
Adults scheduled for laparoscopic sleeve gastrectomy with ASA I-III. Excludes patients with severe liver/kidney impairment, recent MI, uncontrolled anxiety/psychiatric disorders, or recent use of local anesthetics/steroids.
04
Endpoints
Primary
Postoperative Pain Scores
Opioid rescue medication use
Patient Global Assessment
Discharge readiness assessment per MPADSS
Subject's satisfaction with postoperative pain control
Secondary
Adverse Events
Episodes of nausea/vomiting and need for antiemetics
Cost of pain management
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