Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Benign Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05082441
• Other study ID #: IRB20-050
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Neoplasm
• Neoplasms
• Soft Tissue Neoplasms

Intervention

Drug:
• Liposomal bupivacaine
Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
• Bupivacaine Hydrochloride
plain bupivacaine subcutaneous injection as standard of care control

Locations

Country	Name	City	State
United States	Good Samaritan Regional Medical Center	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Samaritan Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Musculoskeletal Tumor Society Score (MSTS score)	MSTS score postop compared to baseline	First 7 days postoperatively
Primary	Opioid Use	Amount of morphine equivalents used for postoperative pain control	first 7 days postoperatively
Secondary	Pain Score	VAS pain score	First 7 days postoperatively