NCT02515851

Brief Summary

For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease the need for post-operative narcotic pain medication.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_4

Status
terminated

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

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

August 3, 2015

Results QC Date

July 5, 2017

Last Update Submit

October 17, 2017

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • Pain Medication Usage

    the amount of pain medication used in the three days following surgery.

    three days

Secondary Outcomes (3)

  • Total Narcotic Pain Medication Usage

    7 days after surgery

  • Passive Wrist Range of Motion

    7 days after surgery

  • Over Satisfaction

    7 days after surgery

Study Arms (2)

Active Group

ACTIVE COMPARATOR

Group that receives actual liposomal bupivacaine injections

Drug: Exparel

Placebo Group

PLACEBO COMPARATOR

Group that receives placebo injections

Drug: Placebo

Interventions

ExparelDRUG
Also known as: Liposomal Bupivacaine
Active Group
PlaceboDRUG
Placebo Group

Eligibility Criteria

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

You may qualify if:

  • Isolated distal radius fracture

You may not qualify if:

  • No Access to a telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Results Point of Contact

Title
Nancy Alsip
Organization
University Louisville
nlalsi01@exchange.louisville.edu
502-852-2610

Study Officials

  • David Seligson, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 20, 2017

Results First Posted

November 20, 2017

Record last verified: 2017-10