Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Samaritan Health Services

Status and phase: Unknown; Phase 4

Conditions: Benign Neoplasm

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05082441

IRB20-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

experimental

Experimental group

Description:

Exparel group

Treatment:

Drug: Liposomal bupivacaine

control

Active Comparator group

Description:

plain bupivacaine

Treatment:

Drug: Bupivacaine Hydrochloride