Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Phase 4

• Conditions: Benign Neoplasm
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT05082441
• Lead Sponsor: Samaritan Health Services

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Liposomal bupivacaine	Exparel group
control	Bupivacaine Hydrochloride	plain bupivacaine

Primary Outcome Measures

Name	Time	Method
Opioid Use	first 7 days postoperatively	Amount of morphine equivalents used for postoperative pain control

Secondary Outcome Measures

Name	Time	Method
Pain Score	First 7 days postoperatively	VAS pain score

Trial Locations

Locations (1)

Good Samaritan Regional Medical Center; 🇺🇸 Corvallis, Oregon, United States