- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221415
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Withdrawn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
-
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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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.
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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.
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Popliteal Ultrasound
Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
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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.
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|
Femoral Ultrasound
Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the ultrasound used to locate the nerve.
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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
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within the first 45 minutes after injection of local anesthestic
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
effectiveness of block
Time Frame: within 1 hour of injection
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within 1 hour of injection
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time taken to locate the target nerve and inject local anesthetic
Time Frame: within 45 minutes prior to injection
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within 45 minutes prior to injection
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|
incidence of vascular puncture
Time Frame: within 30 minutes of injection
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within 30 minutes of injection
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incidence of adverse events
Time Frame: within 2 weeks of the day of surgery
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within 2 weeks of the day of surgery
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patient satisfaction
Time Frame: within 2 weeks of the date of surgery
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within 2 weeks of the date of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Domingo-Triado V, Selfa S, Martinez F, Sanchez-Contreras D, Reche M, Tecles J, Crespo MT, Palanca JM, Moro B. Ultrasound guidance for lateral midfemoral sciatic nerve block: a prospective, comparative, randomized study. Anesth Analg. 2007 May;104(5):1270-4, tables of contents. doi: 10.1213/01.ane.0000221469.24319.49.
- Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4.
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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