A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery

Sponsor
Jose Soberon, MD (Other)
Overall Status
Completed
CT.gov ID
NCT01550094
Collaborator
(none)
60
1
43
1.4

Study Details

Study Description

Brief Summary

One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.

Detailed Description

The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.

Many studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.

The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery

    • Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively

    • ASA status I-IV

    • Ability to understand and provide informed consent

    Exclusion Criteria:
    • True allergy, not sensitivity, to any of the following substances:

    Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol

    • Pregnancy

    • Evidence of infection at or near the proposed needle insertion site

    • Unstable or undetermined neurologic disease of the lower extremity

    • Chronic pain patients

    • Patient refusal or inability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ochsner Clinic Foundation New Orleans Louisiana United States 70121

    Sponsors and Collaborators

    • Jose Soberon, MD

    Investigators

    • Principal Investigator: Jose Soberon, MD, Ochsner Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jose Soberon, MD, Anesthesiologist, Ochsner Health System
    ClinicalTrials.gov Identifier:
    NCT01550094
    Other Study ID Numbers:
    • 2011.191.B
    • 2011.191.B
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Oct 14, 2015
    Last Verified:
    Oct 1, 2015

    Study Results

    No Results Posted as of Oct 14, 2015