Exparel Injectable Product for Musculoskeletal Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Morristown Medical Center, Morristown, NJ
Musculoskeletal Diseases+2 More
Exparel Injectable Product - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions

  • Musculoskeletal Diseases
  • Soft Tissue Mass

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 14 days

14 days
Medication Consumption
Pain Outcomes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Exparel Group
1 of 2
Multi-Drug Cocktail Group
1 of 2
Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: Exparel Injectable Product · No Placebo Group · Phase 2

Exparel Group
Drug
Experimental Group · 1 Intervention: Exparel Injectable Product · Intervention Types: Drug
Multi-Drug Cocktail Group
Drug
Experimental Group · 1 Intervention: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exparel Injectable Product
2017
Completed Phase 4
~220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days
Closest Location: Morristown Medical Center · Morristown, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
2021First Recorded Clinical Trial
1 TrialsResearching Musculoskeletal Diseases
91 CompletedClinical Trials

Who is running the clinical trial?

Morristown Medical CenterLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are undergoing surgery for a soft tissue tumor intraoperatively injected with the cocktail.
Patients undergoing resection of their soft tissue tumor intraoperatively injected with Exparel.
The 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.