NCT02072135

Brief Summary

This study involves a drug called Exparel that has been approved by the US Food and Drug Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain reliever. It is being given in this study to see if it provides safe and effective pain relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for as much as 72 hours after surgery. EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the method the study doctors will use to give the patients the drug. Giving the drug by popliteal block involves inserting a small tube in to the back of the knee to deliver the drug. The study doctors wish to determine if patients undergoing ankle surgery and receiving this drug have less pain and less need for narcotic medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

February 24, 2014

Last Update Submit

September 22, 2016

Conditions

Ankle Fracture

Outcome Measures

Primary Outcomes (1)

  • pain

    Subject will be asked highest pain score and amount of narcotics used

    72 hours post operation

Secondary Outcomes (1)

  • side effect of drug

    72 hours

Study Arms (1)

Exparel

EXPERIMENTAL

Exparel 266mg

Drug: Exparel

Interventions

ExparelDRUG
Also known as: liposomal bupivacaine
Exparel

Eligibility Criteria

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

You may qualify if:

  • ankle fracture open reduction or internal fixation
  • American Society of Anesthesiologists rating of I-III
  • have a working telephone

You may not qualify if:

  • non English speaking
  • BMI \>40
  • allergy or contraindication to local anesthetics
  • history of drug abuse
  • impaired kidney function, rheumatoid arthritis or loss of sensation in extremities
  • abnormal liver function
  • long term (greater than 10 days) use of NSAIDS
  • uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Jean Daniel Eloy, MD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)