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

NCT05355597 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 1429450
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Diseases; Soft Tissue Mass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Medication Consumption

  14 days

Study Arms (2)

Exparel Group

EXPERIMENTAL

70 subjects will receive Exparel

Drug: Exparel Injectable Product

Multi-Drug Cocktail Group

EXPERIMENTAL

70 subjects will receive a Multi-drug Cocktail

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

Interventions

Exparel Injectable Product DRUG

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

Exparel Group

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

Multi-Drug Cocktail Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pediatric Patients
• Patients without soft tissue tumors
• Tylenol or oxycodone allergy

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Related Publications (4)

• Kelly MA. Current Postoperative Pain Management Protocols Contribute to the Opioid Epidemic in the United States. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S5-8.

  PMID: 26447431 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Ranade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. doi: 10.1002/j.1552-4604.1989.tb03403.x.

  PMID: 2674208 BACKGROUND

• Barrington JW. Efficacy of Periarticular Injection With a Long-Acting Local Analgesic in Joint Arthroplasty. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S13-6.

  PMID: 26447426 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Epinephrine; Clonidine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This a double blinded study in which the investigator nor subjects will know which drug he or she receives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 2, 2022
• Study Start: January 27, 2021
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)