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WithdrawnNCT01221415Updated Apr 27, 2022

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

An observational study in Orthopedic, sponsored by Ochsner Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Ochsner Health System · Observational

Why this study was withdrawn
not enough manpower
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Orthopedic
03

In context

Lead sponsor

Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Allergy to:

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

Observational model
Other
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. time from injection of local anesthetic to adequate surgical anesthesia

    Time frame: within the first 45 minutes after injection of local anesthestic

Secondary outcomes

  1. effectiveness of block

    Time frame: within 1 hour of injection

  2. time taken to locate the target nerve and inject local anesthetic

    Time frame: within 45 minutes prior to injection

  3. incidence of vascular puncture

    Time frame: within 30 minutes of injection

  4. incidence of adverse events

    Time frame: within 2 weeks of the day of surgery

  5. patient satisfaction

    Time frame: within 2 weeks of the date of surgery

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Study locations

1 site
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
08

References and documents

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. PubMed 17456685 ↗
  • 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. PubMed 9840855 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01221415
Lead sponsor
Ochsner Health System
Responsible party
Leslie Thomas (Anesthesiologist, Ochsner Health System) — Principal investigator
First posted
Oct 15, 2010
Start date
Jan 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Apr 27, 2022

Study contacts

Leslie Thomas, MD
principal investigator · Ochsner Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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