NCT01756560

Brief Summary

Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.

Trial Health

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Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 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
5 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2019

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

December 20, 2012

Results QC Date

June 16, 2016

Last Update Submit

April 22, 2019

Conditions

Duration of Pain Relief

Keywords

anterior cruciate ligamentblock duration

Outcome Measures

Primary Outcomes (1)

  • Analgesia Duration

    72 hours

Study Arms (2)

control

ACTIVE COMPARATOR

in this group, plain bupivacaine will be used to block femoral and sciatic nerve

Drug: Bupivacaine

Dexamethasone

EXPERIMENTAL

Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve

Drug: dexamethsoneDrug: Bupivacaine

Interventions

dexamethsoneDRUG
Dexamethasone
BupivacaineDRUG
Dexamethasonecontrol

Eligibility Criteria

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

You may qualify if:

  • age 18-75, no contraindication to regional anesthesia

You may not qualify if:

  • 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

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
TARIQ MALIK
Organization
University of Chicago
tmalik@dacc.uchicago.edu
773-8342643

Study Officials

  • Tariq Malik, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

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

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 14, 2019

Results First Posted

May 14, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)