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

NCT01579747 | Completed Phase 4 Results

• 1 other identifier: UNMLAM_USvsNSobese
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

nerve stimulation; ultrasound; sciatic nerve block; popliteal block; obese

Outcome Measures

Primary Outcomes (1)

• Procedural Time

  Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique

  less than 30 minutes

Secondary Outcomes (1)

• Number of Redirections

  6 months

Study Arms (2)

Nerve stimulation sciatic nerve block

PLACEBO COMPARATOR

Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation

Procedure: Nerve stimulation

Ultrasound guided sciatic nerve block

ACTIVE COMPARATOR

Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Using ultrasound for nerve localization when performing a sciatic nerve block via the lateral popliteal approach

Ultrasound guided sciatic nerve block

Nerve stimulation PROCEDURE

Using nerve stimulation for nerve localization in sciatic nerve blocks via the lateral popliteal approach

Nerve stimulation sciatic nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Obesity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Limitations and Caveats

We attempted to minimize performance bias by only involving staff anesthesiologists with years of experience in peripheral nerve blockade using both guidance modalities.

Results Point of Contact

• Title: Nicholas Lam
• Organization: Univeristy of New Mexico

nlam@salud.unm.edu

505 272 2610

Study Officials

• Nicholas Lam, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 18, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 24, 2014
• Results First Posted: December 19, 2013

Record last verified: 2013-12

Locations

US (1)