Clinical trial · Interventional
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"
NCT05355597CI-TRIAL-00088355terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Physician left institution
Summary
Brief summary (as posted)
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Musculoskeletal Diseases | — | UNRESOLVED | — |
| Soft Tissue Mass | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exparel Injectable Product | Drug | — | UNRESOLVED |
| Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exparel Group
- description
- 70 subjects will receive Exparel
- interventionNames
- Drug: Exparel Injectable Product
- type
- EXPERIMENTAL
- label
- Multi-Drug Cocktail Group
- description
- 70 subjects will receive a Multi-drug Cocktail
- interventionNames
- Drug: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)
Primary outcomes (1)
- measure
- Pain Outcomes
- timeFrame
- 14 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All primary soft tissue tumors * Any adult patient (over 18 years old) with a soft tissue tumor confirmed with advanced imaging. Two different study groups will be examined: * Those patients undergoing resection of their soft tissue tumor intraoperatively injected with Exparel * Those patients undergoing resection of their soft tissue tumor intraoperatively injected with the cocktail. * Those two groups will be further stratified by anatomic location; Upper vs lower extremity, size; tumors ≥ 10cm, tumors ≥ 5cm, tumors \< 5cm, and depth; superficial vs deep. Exclusion Criteria: * Pediatric Patients * Patients without soft tissue tumors * Tylenol or oxycodone allergy
References
Publications (4)
- RESULTKelly MA. Current Postoperative Pain Management Protocols Contribute to the Opioid Epidemic in the United States. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S5-8. PMID 26447431
- RESULTBramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28. PMID 22285545
- RESULTRanade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. doi: 10.1002/j.1552-4604.1989.tb03403.x. PMID 2674208
- RESULTBarrington JW. Efficacy of Periarticular Injection With a Long-Acting Local Analgesic in Joint Arthroplasty. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S13-6. PMID 26447426