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

NCT05355597 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-04-09

No results posted yet for this 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.

Conditions

  • Musculoskeletal Diseases
  • Soft Tissue Mass

Interventions

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.

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.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2025-03-24
Completion
2025-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05355597 on ClinicalTrials.gov