Tibial Nerve Versus Sciatic Nerve Block

March 17, 2015 updated by: Saint Francis Care

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • total knee replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selective Tibial Nerve Block
Use of selective pain block.
Active Comparator: Control: Sciatic Nerve Block
Use of Sciatic Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measure frequency of foot drop in two groups and compare results.
Upon emergence from general anesthesia and up to 48 hours in the recovery room.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess if levels of pain and analgesic requirements are similar between the two groups.
Time Frame: 24 hours after total knee replacement surgery.
Administer pain scale and monitor use of analgesics to compare levels two groups.
24 hours after total knee replacement surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sanjay Sinha, MD, Saint Francis Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

August 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 09-02-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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