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NCT05751421
Pain Relief After PrimaryTKA
Phase 3 trial testing Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution in Pain, Postoperative in 60 participants. Status unknown.
28 February 2024
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 28 February 2023 |
| Primary completion | 28 February 2024 |
| Estimated completion | 28 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution — full drug profile →
- Bupivacaine HCl 0.5% Injectable Solution — full drug profile →
- primary total knee replacement
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
Rothman Institute Orthopaedics
Who can join
18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05751421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Rothman Institute Orthopaedics trials
Trials by the same sponsor.
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- NCT06484192 — Pain Control After Lumbar Spine Fusion · Phase 4 · enrolling by invitation
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 NCT05751421 (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 Rothman Institute Orthopaedics
- Last refreshed: 2 March 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/NCT05751421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing