The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

March 8, 2017 updated by: Antoun Nader, Northwestern University

A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block

The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feingberg School of Medicine

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.

Exclusion Criteria:

  • Exclusion criteria for the study are patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, the presence of coagulopathy or infection, or pregnancy

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: Bupivacaine
Varying does to determine duration of analgesia following a sciatic nerve block
Drug: Bupivacaine
Varying doses to determine the duration of analgesia
Active Comparator: Ropivacaine
Varying does to determine duration of analgesia following a sciatic nerve block
Drug: Ropivacaine
Varying doses to determine the duration of analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL
Time Frame: 3 days
Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Probabilities for Needle Positioning Above and Below CIEL.
Time Frame: 1 Day
The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.
1 Day

Collaborators and Investigators

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

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Antoun Nader, MD, Northwestern University Feinberg School Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00035380

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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