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

Musculoskeletal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355597
• Other study ID #: 1429450
• Status: Recruiting
• Phase: Phase 2
• Start date: January 27, 2021
• Est. completion date: July 7, 2023

Study information

• Verified date: April 2022
• Source: Morristown Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Soft Tissue Mass
• Soft Tissue Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Morristown Medical Center	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Morristown Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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 arthroplas — View Citation

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. — View Citation

Ranade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication Consumption	Patient will self-report how much medication he or she took each day post-operatively.	14 days