NCT01756586

Brief Summary

Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

December 20, 2012

Results QC Date

June 16, 2016

Last Update Submit

May 24, 2017

Conditions

Keywords

popliteal blockanalgesia duration

Outcome Measures

Primary Outcomes (1)

  • Increase in the Duration of Block

    3 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Plain bupivacaine

Drug: Bupivacaine

Experimental

EXPERIMENTAL

Bupivacaine with Dexamethasone

Drug: DexamethasoneDrug: Bupivacaine

Interventions

Experimental

Control

ControlExperimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75
  • foot surgery
  • no contraindication to regional anesthesia

You may not qualify if:

  • opioid dependent
  • chronic pain condition
  • peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

DexamethasoneBupivacaine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
TARIQ MALIK
Organization
University of Chicago

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 27, 2012

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 27, 2017

Results First Posted

June 27, 2017

Record last verified: 2017-05

Locations