We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550094
First Posted: March 9, 2012
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jose Soberon, MD, Ochsner Health System
  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

Further study details as provided by Jose Soberon, MD, Ochsner Health System:

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: October 2015
Primary Completion Date: October 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01550094


Locations
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Jose Soberon, MD
Investigators
Principal Investigator: Jose Soberon, MD Ochsner Health System
  More Information

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 ( Other Identifier: Ochnser Clinic Foundation Institutional Review Board )
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Jose Soberon, MD, 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
Fractures, Malunited
Leg Injuries
Crush Injuries
Joint Loose Bodies
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases