NCT03020563

Brief Summary

To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

January 5, 2017

Last Update Submit

October 11, 2018

Conditions

Clavicle Fracture

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Pain Scale Averages between the two treatments

    Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain.

    72 hours post surgery

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

Time release Bupivacaine

Drug: Liposomal Bupivacaine

Bupivacaine

PLACEBO COMPARATOR

Immediate Acting Bupivacaine

Drug: Bupivacaine

Interventions

Liposomal BupivacaineDRUG

Liposomal Bupivacaine

Liposomal Bupivacaine
BupivacaineDRUG

Bupivacaine

Bupivacaine

Eligibility Criteria

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

You may qualify if:

  • Mid-shaft Clavicle Fracture treated with ORIF

You may not qualify if:

  • Unable to be contacted for 72 hours post surgery
  • Other concurrent surgical procedures
  • Chronic narcotic user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 13, 2017

Study Start

August 23, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)