Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Study Overview
=================
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.

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

Conditions
-----------------
Benign Neoplasm

Intervention / Treatment
-----------------
* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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