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Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05082441
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Samaritan Health Services

Study Description
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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.

Condition or disease Intervention/treatment Phase
Benign Neoplasm Drug: Liposomal bupivacaine Drug: Bupivacaine Hydrochloride Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental
Exparel group
 Drug: Liposomal bupivacaine
Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
Other Name: Experimental
Active Comparator: control
plain bupivacaine
 Drug: Bupivacaine Hydrochloride
plain bupivacaine subcutaneous injection as standard of care control
Other Name: Control


Outcome Measures
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Primary Outcome Measures :
  1. Opioid Use [ Time Frame: first 7 days postoperatively ]
    Amount of morphine equivalents used for postoperative pain control


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: First 7 days postoperatively ]
    VAS pain score


Other Outcome Measures:
  1. Musculoskeletal Tumor Society Score (MSTS score) [ Time Frame: First 7 days postoperatively ]
    MSTS score postop compared to baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05082441


Locations
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United States, Oregon
Good Samaritan Regional Medical Center Recruiting
Corvallis, Oregon, United States, 97330
Contact: Jared Sanderford, DO    541-768-5111    jareds@samhealth.org   
Contact: Nicolas Tedesco, DO    541-768-4811    ntedesco@samhealth.org   
Sponsors and Collaborators
Samaritan Health Services
More Information
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Responsible Party: Samaritan Health Services
ClinicalTrials.gov Identifier: NCT05082441    
Other Study ID Numbers: IRB20-050
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021

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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
Additional relevant MeSH terms:
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Soft Tissue Neoplasms
Neoplasms
Neoplasms by Site
Bupivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents