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

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ClinicalTrials.gov Identifier: NCT01579747
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : December 19, 2013
Last Update Posted : January 24, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Procedure: Ultrasound Procedure: Nerve stimulation Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : July 2012
Primary Completion Date : December 2012
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Number of Redirections [ Time Frame: 6 months ]
    Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.


Eligibility Criteria

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 Posted: April 18, 2012    Key Record Dates
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