Tibial Nerve Versus Sciatic Nerve Block

This study has been completed.

Sponsor:

Information provided by:

Saint Francis Care

ClinicalTrials.gov Identifier:

NCT01415193

First received: August 1, 2011

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 1, 2011

Last Updated Date

August 10, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. [ Time Frame: Upon emergence from general anesthesia and up to 48 hours in the recovery room. ] [ Designated as safety issue: No ]

Measure frequency of foot drop in two groups and compare results.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01415193 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess if levels of pain and analgesic requirements are similar between the two groups. [ Time Frame: 24 hours after total knee replacement surgery. ] [ Designated as safety issue: No ]

Administer pain scale and monitor use of analgesics to compare levels two groups.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tibial Nerve Versus Sciatic Nerve Block

Official Title ^ICMJE

Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty

Brief Summary

The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Post Operative Analgesia

Intervention ^ICMJE

Procedure: Selective Tibial Nerve block
Use of selective pain block.
Procedure: Sciatic Nerve Block
Use of Sciatic Nerve Block

Study Arm (s)

Experimental: Selective Tibial Nerve Block
Intervention: Procedure: Selective Tibial Nerve block
Active Comparator: Control: Sciatic Nerve Block
Intervention: Procedure: Sciatic Nerve Block

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

total knee replacement

Exclusion Criteria:

History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01415193

Other Study ID Numbers ^ICMJE

009-02-002

Has Data Monitoring Committee

Responsible Party

Sanjay Sinha, Saint Francis Hospital

Study Sponsor ^ICMJE

Saint Francis Care

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sanjay Sinha, MD

Saint Francis Memorial Hospital

Information Provided By

Saint Francis Care

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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