Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial

Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Study Overview

• Status: Recruiting
• Conditions: Benign Neoplasm
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Detailed Description

Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.

The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Recruiting
      • Good Samaritan Regional Medical Center
      • Contact: Jared Sanderford, DO; Phone Number: 541-768-5111; Email: jareds@samhealth.org
      • Contact: Nicolas Tedesco, DO; Phone Number: 541-768-4811; Email: ntedesco@samhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All benign soft tissue tumors greater than one cubic cm
• Adults 18 years and older

Exclusion Criteria:

• Pregnant females
• Women who are breastfeeding
• Less than 18 years old
• Malignant tumors
• Tumors smaller than 1 cubic cm
• Allergy to Exparel
• Patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day
• Allergy to amide anesthetics
• bone tumors
• Patients unable to comply with the study standards and follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; Exparel group	Drug: Liposomal bupivacaine; Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine; Other Names: Experimental
Active Comparator: control; plain bupivacaine	Drug: Bupivacaine Hydrochloride; plain bupivacaine subcutaneous injection as standard of care control; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Amount of morphine equivalents used for postoperative pain control	first 7 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	VAS pain score	First 7 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal Tumor Society Score (MSTS score)	MSTS score postop compared to baseline	First 7 days postoperatively

Collaborators and Investigators

• Sponsor: Samaritan Health Services

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Soft Tissue Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB20-050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No