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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2025-03-24

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.

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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.

Conditions

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Musculoskeletal Diseases Soft Tissue Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Total of 140 subjects are recruited. Group A Receives one drug (70) and Group B receives the other drug (70)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

This a double blinded study in which the investigator nor subjects will know which drug he or she receives.

Study Groups

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Exparel Group

70 subjects will receive Exparel

Group Type EXPERIMENTAL

Exparel Injectable Product

Intervention Type DRUG

Both drugs have same desired effect. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.

Multi-Drug Cocktail Group

70 subjects will receive a Multi-drug Cocktail

Group Type EXPERIMENTAL

Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)

Intervention Type DRUG

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.

Interventions

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Exparel Injectable Product

Both drugs have same desired effect. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.

Intervention Type DRUG

Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)

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.

Intervention Type DRUG

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.