Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

• ClinicalTrials.gov Identifier: NCT05082441
• Recruitment Status: Recruiting
• First Posted: October 19, 2021
• Last Update Posted: October 19, 2021
• Sponsor: Samaritan Health Services
• Information provided by (Responsible Party): Samaritan Health Services

Tracking Information

• First Submitted Date: October 5, 2021
• First Posted Date: October 19, 2021
• Last Update Posted Date: October 19, 2021
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2021)

Opioid Use [ Time Frame: first 7 days postoperatively ]

Amount of morphine equivalents used for postoperative pain control

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 5, 2021)

Pain Score [ Time Frame: First 7 days postoperatively ]

VAS pain score

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 5, 2021)

Musculoskeletal Tumor Society Score (MSTS score) [ Time Frame: First 7 days postoperatively ]

MSTS score postop compared to baseline

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection
• Official Title: Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Diagnostic
• Condition: Benign Neoplasm

Intervention

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

Study Arms

• Experimental: experimental
  Exparel group
  Intervention: Drug: Liposomal bupivacaine
• Active Comparator: control
  plain bupivacaine
  Intervention: Drug: Bupivacaine Hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 5, 2021): 140
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2022
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05082441
• Other Study ID Numbers: IRB20-050
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Samaritan Health Services
• Original Responsible Party: Same as current
• Current Study Sponsor: Samaritan Health Services
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Samaritan Health Services
• Verification Date: October 2021