A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia

April 19, 2022 updated by: Leslie Thomas, Ochsner Health System
The primary objective of this study is to compare ultrasound versus nerve stimulator techniques for nerve localization when performing peripheral nerve blocks. Specifically the investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The investigators will be looking for differences in 1) time taken to locate the target nerve and inject local anesthetic 2) time from injection of local anesthetic to adequate surgical anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of adverse events 6) patient satisfaction.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

After obtaining informed consent, subjects will be randomized to either the ultrasound or nerve stimulator groups as the method for nerve localization prior to peripheral block placement.

Study Type

Observational

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

    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 18 years of age or older undergoing outpatient knee arthroscopy or lower leg/foot surgery as well as shoulder arthroscopy.

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical status I-III
  • Arthroscopic knee surgery or Lower leg/foot surgery as well as shoulder arthroscopy
  • Outpatient status
  • Patient preference for a regional anesthetic
  • Subjects should be capable of giving informed consent

Exclusion Criteria:

  • Allergy to:

    • Local anesthetics
    • Hydromorphone
    • Propofol
    • Midazolam
  • Patient refusal
  • Infection at the injection site
  • Peripheral Neuropathy

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

Cohorts and Interventions

Group / Cohort
Interscalene Ultrasound
Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
Interscalene Nerve Stimulator
Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.
Popliteal Ultrasound
Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
Popliteal Nerve Stimulator
Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.
Femoral Ultrasound
Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
Femoral Nerve Stimulator
Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time from injection of local anesthetic to adequate surgical anesthesia
Time Frame: within the first 45 minutes after injection of local anesthestic
within the first 45 minutes after injection of local anesthestic

Secondary Outcome Measures

Outcome Measure
Time Frame
effectiveness of block
Time Frame: within 1 hour of injection
within 1 hour of injection
time taken to locate the target nerve and inject local anesthetic
Time Frame: within 45 minutes prior to injection
within 45 minutes prior to injection
incidence of vascular puncture
Time Frame: within 30 minutes of injection
within 30 minutes of injection
incidence of adverse events
Time Frame: within 2 weeks of the day of surgery
within 2 weeks of the day of surgery
patient satisfaction
Time Frame: within 2 weeks of the date of surgery
within 2 weeks of the date of surgery

Collaborators and Investigators

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

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.

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

January 1, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (ESTIMATE)

October 15, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2007.127.A (OTHER: Ochnser Clinic Foundation Institutional Review Board)

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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