Musculoskeletal Diseases Clinical Trial
Official title:
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"
Verified date | April 2022 |
Source | Morristown Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | July 7, 2023 |
Est. primary completion date | July 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Morristown Medical Center | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Morristown Medical Center |
United States,
Barrington 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. — View Citation
Bramlett 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 arthroplas — View Citation
Kelly 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. — View Citation
Ranade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Outcomes | Pain will be recorded on a sheet for each patient. Self-reported, patient will describe pain each day on a scale of 1-10 (10 being the worst) | 14 days | |
Secondary | Medication Consumption | Patient will self-report how much medication he or she took each day post-operatively. | 14 days |
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