Circumferential Spread of Anesthetic and Success in Sciate Nerve Blockade - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00802581

Purpose

Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve.

Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.

Condition	Intervention
Sciatic Nerve Blockade for Foot/Ankle Surgery	Procedure: Circumferential spread of local anesthetic Procedure: Non-circumferential spread of local anesthetic

MedlinePlus related topics: Anesthesia Foot Health Surgery Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Does Ensuring Circumferential Local Anesthetic Spread Improve the Success of Ultrasound Guided Sciatic Nerve Block at the Popliteal Fossa?

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Onset time of sciatic nerve blockade. [ Time Frame: Every 5 minutes for 30 minutes after anesthetic injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ensuring circumferential spread of local anesthetic around the sciatic nerve.	Procedure: Circumferential spread of local anesthetic The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.
2: Active Comparator Single shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread.	Procedure: Non-circumferential spread of local anesthetic The anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

English-speaking
ASA physical status I-III
18-85 years of age, inclusive
50-110 kg, inclusive
150 cm of height or grater
Scheduled for elective foot or ankle surgery

Exclusion Criteria:

Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
Pregnancy
Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
History of alcohol or drug dependency/abuse
History of long term opioid intake
History of significant psychiatric conditions that may affect patient assessment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802581

Contacts

Contact: Alex Kerr

416 603-5800 ext 6237

alex.kerr@uhn.on.ca

Locations

Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5W 2S8

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Richard Brull, MD

University Health Network, Toronto

More Information

No publications provided

Responsible Party:	University Health Network ( Dr. Richard Brull )
Study ID Numbers:	08-0728-B
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802581 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

sciatic nerve block
local anesthetic
lidocaine
ankle surgery

foot surgery
ultrasound-guided regional anesthesia
circumferential spread
anesthetic infiltration

Study placed in the following topic categories:

Lidocaine
Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009