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

Last updated: April 7, 2025
Sponsor: Atlantic Health System
Overall Status: Terminated

Phase

2

Condition

Musculoskeletal Diseases

Treatment

Exparel Injectable Product

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

Clinical Study ID

NCT05355597
1429450
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All primary soft tissue tumors

  • Any adult patient (over 18 years old) with a soft tissue tumor confirmed withadvanced imaging.

Two different study groups will be examined:

  • Those patients undergoing resection of their soft tissue tumor intraoperativelyinjected with Exparel

  • Those patients undergoing resection of their soft tissue tumor intraoperativelyinjected with the cocktail.

  • Those two groups will be further stratified by anatomic location; Upper vs lowerextremity, size; tumors ≥ 10cm, tumors ≥ 5cm, tumors < 5cm, and depth; superficialvs deep.

Exclusion

Exclusion Criteria:

  • Pediatric Patients

  • Patients without soft tissue tumors

  • Tylenol or oxycodone allergy

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Exparel Injectable Product
Phase: 2
Study Start date:
January 27, 2021
Estimated Completion Date:
March 24, 2025

Study Description

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.

Connect with a study center

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

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