Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05082441 |
Other study ID # |
IRB20-050 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 1, 2020 |
Est. completion date |
September 1, 2022 |
Study information
Verified date |
October 2021 |
Source |
Samaritan Health Services |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.