Text Size

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

This study is currently recruiting participants.
Verified July 2012 by University of New Mexico
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Nicholas Lam, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01579747
First received: April 16, 2012
Last updated: July 8, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Procedural time [ Time Frame: less than 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.


Estimated Enrollment: 54
Study Start Date: July 2012
Estimated Study Completion Date: March 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579747

Contacts
Contact: Nicholas C Lam, MD 8327887789 nlam@salud.unm.edu
Contact: Timothy Petersen, Phd 505-272-1762 TimPetersen@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Nicholas Lam, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01579747     History of Changes
Other Study ID Numbers: UNMLAM_USvsNSobese
Study First Received: April 16, 2012
Last Updated: July 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013