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NCT03827213
Exparel Interscalene vs Indwelling Catheter
Phase 2 trial testing Exparel in Pain in 23 participants. Terminated before completion.
1 June 2021
Quick facts
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 22 January 2019 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Exparel — full drug profile →
- Indwelling Interscalene Catheter
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Montefiore Medical Center
Who can join
Adults 40 to 74, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 72 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (4 terms — click to expand)
| Reaction | System | Single Shot Interscalene N… | Indwelling Interscalene Ca… |
|---|---|---|---|
| Postoperative Respiratory Complications | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Angina | Cardiac disorders | — | — |
Data from ClinicalTrials.gov NCT03827213 adverse events section.
Sponsor's own description
The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03827213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Montefiore Medical Center trials
Trials by the same sponsor.
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- NCT06919094 — A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults · NA · recruiting
- NCT07076069 — The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair · Phase 4 · recruiting
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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 NCT03827213 (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 Montefiore Medical Center
- Last refreshed: 7 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/NCT03827213.
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