Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    140
  • sponsor
    Samaritan Health Services
Updated on 24 October 2021
Accepts healthy volunteers

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.

Details
Condition Cancer (Pediatric), Ewing's Family Tumors, Cancer/Tumors, Neoplasms, Cancer
Treatment Liposomal bupivacaine, Bupivacaine Hydrochloride
Clinical Study IdentifierNCT05082441
SponsorSamaritan Health Services
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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