Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery

June 20, 2012 updated by: Mayo Clinic

A Study to Determine the Quality of Sensory and Motor Blockade of Popliteal Sciatic Nerve Block Catheters Placed Under Ultrasound Guidance With and Without Nerve Stimulation

Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville

Exclusion criteria:

  • emergency surgery
  • peripheral neuropathy in the distribution of the sciatic nerve on the operative side
  • history of recent alcohol or drug abuse
  • allergy to local anesthetics
  • pregnancy
  • coagulopathy
  • subjects declined to participate

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nerve stimulation and Ultrasound
Procedure: Placement of nerve block catheter
Placement of nerve block catheter with nerve stimulator and ultrasound
Procedure: Placement of nerve block catheter
Placement of nerve block catheter with ultrasound only
Active Comparator: Ultrasound without nerve stimulation
Procedure: Placement of nerve block catheter
Placement of nerve block catheter with nerve stimulator and ultrasound
Procedure: Placement of nerve block catheter
Placement of nerve block catheter with ultrasound only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete motor and sensory anesthesia in the sciatic nerve distribution.
Time Frame: Upon block placement
Upon block placement

Collaborators and Investigators

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

Sponsor

Mayo Clinic

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

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07-008192

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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