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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ochsner Health System
Sponsor:
Information provided by (Responsible Party):
Jose Soberon, MD, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01550094
First received: March 7, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition
Strain of Muscle and/or Tendon of Lower Leg
Fracture of Lower Leg
Crushing Injury of Lower Leg
Fracture Malunion - Ankle and/ or Foot
Complete Tear, Ankle and/or Foot Ligament
Pathological Fracture - Ankle and/or Foot
Loose Body in Joint of Ankle and/or Foot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Severely and morbidly obese patients scheduled for foot or ankle surgery.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550094

Contacts
Contact: Jose Soberon, MD 504-842-3755 jsoberon@ochsner.org

Locations
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Soberon       jsoberon@ochsner.org   
Sponsors and Collaborators
Jose Soberon, MD
Investigators
Principal Investigator: Jose Soberon, MD Ochsner Clinic Foundation
  More Information

No publications provided

Responsible Party: Jose Soberon, MD, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01550094     History of Changes
Other Study ID Numbers: 2011.191.B, 2011.191.B
Study First Received: March 7, 2012
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
obese
regional anesthesia
anesthesia
anesthesiology
surgery
foot
foot surgery
ankle
ankle surgery
orthopedics
orthopedic surgery
sports medicine
sports medicine surgery
Ochsner Hospital
Ochsner Clinic
New Orleans
Louisiana
Jefferson
Soberon

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Spontaneous
Joint Loose Bodies
Fractures, Malunited
Leg Injuries
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014