Clinical trial NCT01550094: A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery
Official title: Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: 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
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely and morbidly obese patients scheduled for foot or ankle surgery.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Jose Soberon, MD
role: PRINCIPAL_INVESTIGATOR
References: