The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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In recent years, there has been a substantial push to create a post-surgical protocol consisting of multimodal analgesia across multiple surgical subspecialties to decrease narcotic consumption and cost1. The negative side effects of narcotics and their addiction potential are well understood. One of the modes of analgesia currently in use to mitigate surgical pain is some form of local anesthetic. Increasing the duration of analgesia has been sought after since its inception. Subsequently, longer acting anesthetics like bupivacaine have been implemented as well as supplementing their use with other drugs, such as epinephrine, to increase their effect duration and overall efficacy2. This has led to the development of Liposomal Bupivicaine or Exparel (TM, Parsippany NJ etc.) Exparel works by infusing liposomes in the administration of the long acting local analgesic which entrap the biologically active drug and slowly release it over a period of 72-96 hours 3-4. Thus, post-operative pain can be managed via direct injection of the drug at the surgical site with upwards to four days of pain relief. Exparel has been studied extensively in the surgical literature; although within orthopedics, it has been primarily in regard to arthroplasty5. There has yet to be a study to illicit the best form of post-operative pain control in the world of orthopedic oncology, specifically in soft tissue tumors. 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.

Official Title
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The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors

Conditions
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Musculoskeletal Diseases, Soft Tissue Mass

Intervention / Treatment
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* Drug: Exparel Injectable Product
* Drug: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Total of 140 subjects are recruited. Group A Receives one drug (70) and Group B receives the other drug (70)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel Group<br>70 subjects will receive Exparel | Drug: Exparel Injectable Product<br>* Both drugs have same desired effect. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.<br>|
| Experimental: Multi-Drug Cocktail Group<br>70 subjects will receive a Multi-drug Cocktail | Drug: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)<br>* Same desired effect as Exparel but different mechanism of action. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Consumption | Patient will self-report how much medication he or she took each day post-operatively. | 14 days |