NCT05082441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

October 5, 2021

Last Update Submit

October 5, 2021

Conditions

Benign Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Opioid Use

    Amount of morphine equivalents used for postoperative pain control

    first 7 days postoperatively

Secondary Outcomes (1)

  • Pain Score

    First 7 days postoperatively

Other Outcomes (1)

  • Musculoskeletal Tumor Society Score (MSTS score)

    First 7 days postoperatively

Study Arms (2)

experimental

EXPERIMENTAL

Exparel group

Drug: Liposomal bupivacaine

control

ACTIVE COMPARATOR

plain bupivacaine

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaineDRUG

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

Also known as: Experimental
experimental
Bupivacaine HydrochlorideDRUG

plain bupivacaine subcutaneous injection as standard of care control

Also known as: Control
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All benign soft tissue tumors greater than one cubic cm
  • Adults 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Regional Medical Center

Corvallis, Oregon, 97330, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 19, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

US(1)