Musculoskeletal Diseases

All Conditions

Neoplasms

Soft Tissue Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Antihypertensive Agents

Analgesics

Anesthetics

Epinephrine

Racepinephrine

Epinephryl borate

Clonidine

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Sympatholytics

70 subjects will receive a Multi-drug Cocktail

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

Exparel Injectable Product

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 (Ropivicaine, Epinephrine, Ketolorac, Clonidine)

tyler hoskins, BA

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.

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.

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

This a double blinded study in which the investigator nor subjects will know which drug he or she receives.

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

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

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)

Patient will self-report how much medication he or she took each day post-operatively.

Morristown Medical Center

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Alberto Bazzocchi, MD, PhD

A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion.

The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Diagnostic yield will be defined as the number of diagnostic core needle biopsies divided by the total number of core needle biopsies. A diagnostic yield \> 94% will be considered sufficient to produce a sample to reach the histological diagnosis.

To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"	NCT05355597	Musculoskeletal... Soft Tissue Mas...	Exparel Injecta... Multi-Drug Cock...	18 Years -	Morristown Medical Center
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors	NCT03452644	Soft Tissue Neo... Soft Tissue Sar... Soft Tissue Mas... Soft Tissue Les...		-	Istituto Ortopedico Rizzoli
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors	NCT03452644	Soft Tissue Neo... Soft Tissue Sar... Soft Tissue Mas... Soft Tissue Les...		-	Istituto Ortopedico Rizzoli

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