Benign Neoplasm
Conditions
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.
Interventions
DRUGLiposomal bupivacaine
Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
DRUGBupivacaine Hydrochloride
plain bupivacaine subcutaneous injection as standard of care control
Sponsors
Samaritan Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | first 7 days postoperatively | Amount of morphine equivalents used for postoperative pain control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | First 7 days postoperatively | VAS pain score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal Tumor Society Score (MSTS score) | First 7 days postoperatively | MSTS score postop compared to baseline |
Countries
United States
Outcome results
None listed