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NCT05863221: HeronBariatric
ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
Phase 4 trial testing ZYNRELEF 200Mg-6Mg Extended-Release Solution in Post Operative Pain, Acute in 120 participants. Status unknown.
9 October 2024
Quick facts
| Lead sponsor | Dr. Yannis Raftopoulos |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 9 May 2023 |
| Primary completion | 9 October 2024 |
| Estimated completion | 9 October 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ZYNRELEF 200Mg-6Mg Extended-Release Solution — full drug profile →
Conditions studied
- Post Operative Pain, Acute — all drugs for Post Operative Pain, Acute →
- Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
- Postoperative Pain — all drugs for Postoperative Pain →
Sponsor
Dr. Yannis Raftopoulos
Who can join
18 and older, any sex, with Post Operative Pain, Acute or Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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®.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05863221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05863221 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Yannis Raftopoulos
- Last refreshed: 18 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05863221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing