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

April 7, 2025 updated by: James Wittig, Atlantic Health System
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exparel Group
70 subjects will receive Exparel
Drug: 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.
Experimental: Multi-Drug Cocktail Group
70 subjects will receive a Multi-drug Cocktail
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

March 24, 2025

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1429450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared with other researchers, but we do anticipate publishing the results in a journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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