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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leslie Thomas, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01221415
First received: July 21, 2010
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition
Orthopedic

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia

Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • time from injection of local anesthetic to adequate surgical anesthesia [ Time Frame: within the first 45 minutes after injection of local anesthestic ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effectiveness of block [ Time Frame: within 1 hour of injection ] [ Designated as safety issue: No ]
  • time taken to locate the target nerve and inject local anesthetic [ Time Frame: within 45 minutes prior to injection ] [ Designated as safety issue: No ]
  • incidence of vascular puncture [ Time Frame: within 30 minutes of injection ] [ Designated as safety issue: Yes ]
  • incidence of adverse events [ Time Frame: within 2 weeks of the day of surgery ] [ Designated as safety issue: Yes ]
  • patient satisfaction [ Time Frame: within 2 weeks of the date of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: January 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221415

Locations
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Leslie Thomas, MD Ochsner Clinic Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Leslie Thomas, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01221415     History of Changes
Other Study ID Numbers: 2007.127.A, 2007.127.A
Study First Received: July 21, 2010
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014