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

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05355597
Study type	Interventional
Source	Morristown Medical Center
Contact
Status	Recruiting
Phase	Phase 2
Start date	January 27, 2021
Completion date	July 7, 2023

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT04976972` - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation	N/A
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Completed	`NCT05071469` - Comparison of Two Different Treatment Methods	N/A
Completed	`NCT05041400` - Distribution of Knee Isokinetic Angle-specific Moments and Ratios	N/A
Not yet recruiting	`NCT06216028` - Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis	Phase 3
Not yet recruiting	`NCT04932993` - Writing Down Goals	N/A
Completed	`NCT02944448` - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee	Phase 2
Completed	`NCT02256098` - RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA	N/A
Completed	`NCT02269254` - Persona Versus NexGen	N/A
Completed	`NCT02257489` - Phase 1 Study of ACE-083 in Healthy Subjects	Phase 1
Completed	`NCT01979731` - Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders	N/A
Active, not recruiting	`NCT01440153` - Additional Exercise Program in Professional Dancers	N/A
Completed	`NCT00968266` - Improving Beliefs About Medication in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT05222126` - Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome	N/A
Completed	`NCT05062694` - Physical Therapy Management Of The Patient With Central Sensitization
Recruiting	`NCT05564182` - High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain	N/A
Completed	`NCT04009369` - Impacts of Physiotherapy Services in a Quebec Emergency Department	N/A
Completed	`NCT05561452` - The Efficacy of PRP Injection in the Treatment of Rotator Cuff Syndrome	N/A
Recruiting	`NCT05432609` - Standardization and Reproducibility Regarding Scanning Procedures and Measurements of Weight-bearing Cone Beam CT in the Lower Extremity
Completed	`NCT04959162` - The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms