Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery

NCT01542840 | Unknown

• 1 other identifier: 2011.200.C
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve. The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.

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; Disorder of Joint of 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

surgery; orthopedic surgery; foot surgery; leg surgery; ankle surgery; leg; foot; ankle; anesthesia; local anesthesia; regional anesthesia; Ochsner Clinic; Ochsner Hospital; New Orleans; Louisiana; Kristie Osteen, MD

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

All patients undergoing lower leg and/or foot surgery at Ochsner Clinic Foundation's Main Campus.

You may qualify if:

• undergoing lower leg and/or foot surgery
• ASA Physical status I-III
• ability to give informed consent
• age 18 years old or older

You may not qualify if:

• true allergy to local anesthetics, not sensitivity, as determined by investigator
• bilateral lower extremity surgery
• patient refusal
• infection at the injection site
• peripheral neuropathy of lower extremity as documented by electromyography studies

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Study Officials

• Kristie D Osteen, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

US (1)