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

NCT01550094 | Completed

• 1 other identifier: 2011.191.B
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Soberon, MD: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Soberon, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)