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

Complete Tear, Ankle and/or Foot Ligament Clinical Trial

Official title:

Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550094
• Other study ID #: 2011.191.B
• Secondary ID: 2011.191.B
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: October 13, 2015
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Jose Soberon, MD

Country where clinical trial is conducted

United States,