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NCT03043027
Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy
Phase 3 trial testing liposomal bupivicaine in Renal Calculi. Withdrawn.
8 August 2017
Quick facts
| Lead sponsor | Northwell Health |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 8 August 2017 |
| Primary completion | 8 August 2017 |
| Estimated completion | 8 August 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- liposomal bupivicaine — full drug profile →
- Bupivacaine (BUPIVACAINE) — full drug profile →
- Saline Solution
Conditions studied
- Renal Calculi — all drugs for Renal Calculi →
- Postoperative Pain — all drugs for Postoperative Pain →
Sponsor
Northwell Health — full company profile →
Who can join
Adults 18 to 100, any sex, with Renal Calculi or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper urinary tract calculus disease. Despite being minimally invasive, it is associated with significant postoperative pain, often necessitating inpatient hospitalization and narcotic pain medications. Additionally, one of a number of catheters is often left protruding from the access tract for a period of time following the procedure, adding to patient discomfort. Attempts have been made to study peri-tubular or access tract analgesic installation, which have shown promise.1-2 However, no studies, to our knowledge, have examined the use of liposomal bupivacaine preparations in this regard. In this study we hope to prospectively analyze the use of liposomal bupivacaine injected to the access tract site at the time of PCNL and determine its effects on postoperative narcotic requirement and pain scores. Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual care, which involves no injection of local anesthesia. Patients will then be followed during their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge criteria will not change during the course of this study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Liposome Formulation and In Vitro Testing in Non-Physiological Conditions Addressed to Ex Vivo Kidney Perfusion.
Pisani S, Chiesa E, Genta I, Dorati R, et al · · 2022 · cited 10× · PMID 35887348 · DOI 10.3390/ijms23147999
Verify or expand the search:
- PubMed search for NCT03043027
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Renal Calculi
Currently open trials in the same condition.
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- NCT07261995 — Comparison of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calc · NA · recruiting
- NCT06767384 — Diagnostic Accuracy of x Ray Kub in Diagnosing Renal Calculi Keeping CT Scan as Gold Standard · active not recruiting
- NCT03811171 — Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study · NA · recruiting
Other Northwell Health trials
Trials by the same sponsor.
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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 NCT03043027 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwell Health
- Last refreshed: 28 August 2017
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/NCT03043027.
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