Recruiting

Liposomal Bupivacaine

Sponsor:

Samaritan Health Services

Code:

NCT05082441

Conditions

Benign Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Liposomal bupivacaine

Bupivacaine Hydrochloride

Study Details

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.

Conditions

Benign Neoplasm

Study ID

NCT05082441

Start date

Sep 1, 2020

Status verified date

Oct, 2021

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Sep 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: experimental

Exparel group

active comparator: control

plain bupivacaine

Interventions

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

Primary outcome measure

  • Opioid Use [ Time Frame: first 7 days postoperatively ]

Central Contacts and Locations

Locations

Good Samaritan Regional Medical Center

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Jared Sanderford, DO

541-768-5111jareds@samhealth.org

Nicolas Tedesco, DO

541-768-4811ntedesco@samhealth.org

More Information

Sponsor

Samaritan Health Services

Last update posted

Oct 19, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samaritan Health Services on 2021-10-19.