Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | Exparel group |
|
| control | Active Comparator | plain bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Amount of morphine equivalents used for postoperative pain control | first 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | VAS pain score | First 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Musculoskeletal Tumor Society Score (MSTS score) | MSTS score postop compared to baseline | First 7 days postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Regional Medical Center | Recruiting | Corvallis | Oregon | 97330 | United States |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine Hydrochloride | Drug | plain bupivacaine subcutaneous injection as standard of care control |
|
|
| D000588 |
| Amines |