Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection
NCT ID: NCT05082441
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
140 participants
INTERVENTIONAL
2020-09-01
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
experimental
Exparel group
Liposomal bupivacaine
Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
control
plain bupivacaine
Bupivacaine Hydrochloride
plain bupivacaine subcutaneous injection as standard of care control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adults 18 years and older
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samaritan Health Services
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Good Samaritan Regional Medical Center
Corvallis, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB20-050
Identifier Type: -
Identifier Source: org_study_id