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Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579747
First Posted: April 18, 2012
Last Update Posted: January 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Nicholas Lam, University of New Mexico
  Purpose
Ultrasound have been shown to improve the time needed to locate and block nerves in the non obese population. However, its utility is still unknown in the obese population. Ultrasound is known to produce poorer quality images in the obese population. This study aims to find out if it is a better tool for nerve localization compared to the traditional nerve stimulation technique.

Condition Intervention Phase
Postoperative Pain Procedure: Ultrasound Procedure: Nerve stimulation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients

Resource links provided by NLM:


Further study details as provided by Nicholas Lam, University of New Mexico:

Primary Outcome Measures:
  • Procedural Time [ Time Frame: less than 30 minutes ]
    Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique


Secondary Outcome Measures:
  • Number of Redirections [ Time Frame: 6 months ]
    Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.


Enrollment: 25
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Nerve stimulation sciatic nerve block
Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
Procedure: Nerve stimulation
Using nerve stimulation for nerve localization in sciatic nerve blocks via the lateral popliteal approach
Active Comparator: Ultrasound guided sciatic nerve block
Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
Procedure: Ultrasound
Using ultrasound for nerve localization when performing a sciatic nerve block via the lateral popliteal approach

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-3
  • Age 18 and above
  • BMI >30
  • Operations requiring lateral popliteal approach to the sciatic nerve block

Exclusion Criteria:

  • Diabetes
  • Injection site deformities
  • infection at the injection site
  • existing peripheral neuropathy
  • allergy to LA agents
  • Dementia or communication problems
  • Inability to understand or discern temperature difference
  • Any other contraindication to lower limb peripheral nerve block
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579747


Locations
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
VA Palo Alto Health Care System
Investigators
Principal Investigator: Nicholas Lam, MD University of New Mexico
  More Information

Responsible Party: Nicholas Lam, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01579747     History of Changes
Other Study ID Numbers: UNMLAM_USvsNSobese
First Submitted: April 16, 2012
First Posted: April 18, 2012
Results First Submitted: August 19, 2013
Results First Posted: December 19, 2013
Last Update Posted: January 24, 2014
Last Verified: December 2013

Keywords provided by Nicholas Lam, University of New Mexico:
nerve stimulation
ultrasound
sciatic nerve block
popliteal block
obese

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms