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Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Primary Purpose

Benign Neoplasm

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liposomal bupivacaine

Bupivacaine Hydrochloride

About this trial

This is an interventional diagnostic trial for Benign Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Good Samaritan Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental

control

Arm Description

Exparel group

plain bupivacaine

Outcomes

Primary Outcome Measures

Opioid Use

Amount of morphine equivalents used for postoperative pain control

Secondary Outcome Measures

Pain Score

VAS pain score

Full Information

NCT ID

NCT05082441

First Posted

October 5, 2021

Last Updated

October 5, 2021

Sponsor

Samaritan Health Services

1. Study Identification

Unique Protocol Identification Number

NCT05082441

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samaritan Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Neoplasm

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental

Arm Type

Experimental

Arm Description

Exparel group

Arm Title

control

Arm Type

Active Comparator

Arm Description

plain bupivacaine

Intervention Type

Drug

Intervention Name(s)

Liposomal bupivacaine

Other Intervention Name(s)

Experimental

Intervention Description

Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hydrochloride

Other Intervention Name(s)

Control

Intervention Description

plain bupivacaine subcutaneous injection as standard of care control

Primary Outcome Measure Information:

Title

Opioid Use

Description

Amount of morphine equivalents used for postoperative pain control

Time Frame

first 7 days postoperatively

Secondary Outcome Measure Information:

Title

Pain Score

Description

VAS pain score

Time Frame

First 7 days postoperatively

Other Pre-specified Outcome Measures:

Title

Musculoskeletal Tumor Society Score (MSTS score)

Description

MSTS score postop compared to baseline

Time Frame

First 7 days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Good Samaritan Regional Medical Center

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jared Sanderford, DO

Phone

541-768-5111

jareds@samhealth.org

First Name & Middle Initial & Last Name & Degree

Nicolas Tedesco, DO

Phone

541-768-4811

ntedesco@samhealth.org

12. IPD Sharing Statement

Learn more about this trial

Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

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