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Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

This study has been completed.
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute Identifier:
First received: April 20, 2009
Last updated: July 8, 2013
Last verified: July 2013
The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.

Condition Intervention Phase
Disorder of Upper Extremity
Procedure: Ultrasound
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement

Resource links provided by NLM:

Further study details as provided by Shalini Dhir, Lawson Health Research Institute:

Primary Outcome Measures:
  • Neurostimulation versus ultrasound guided infraclavicular catheter placement [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Time taken for complete nerve block [ Time Frame: 14 days ]

Enrollment: 210
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Neurostimulation
Block catheter will be introduced using neurostimulation
Procedure: Ultrasound
Block catheter will be introduced using ultraosound
Active Comparator: Ultrasound
Block catheter will be introduced using ultrasound
Procedure: Ultrasound
Block catheter will be introduced using ultraosound

Detailed Description:
In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-80 yrs
  • Weight 40-100 kg
  • Either sex
  • Height >150 cm
  • American Society of Anesthesiologists physical status 1-3
  • Scheduled for hand or elbow surgery under regional anesthesia

Exclusion Criteria:

  • Inability to give informed consent
  • Refusal of treatment randomization
  • Language barrier
  • Allergy to any medications being used in the study protocol
  • Ongoing major medical or psychiatric problems
  • Chronic pain or narcotic use/abuse
  • Peripheral neuropathy or major neurological problems
  • Scarring in area of blockade
  • Inability to co-operate with post-operative evaluation
  • Major coagulopathy
  • Pregnancy and breast feeding
  • Patients requiring anesthesia of other surgical sites
  • Obese patients (i.e. BMI >40)
  • Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual protocol of care
  Contacts and Locations
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Please refer to this study by its identifier: NCT01136447

Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: Shalini Dhir, MD University of Western Ontario, Canada
  More Information

Responsible Party: Shalini Dhir, DR., Lawson Health Research Institute Identifier: NCT01136447     History of Changes
Other Study ID Numbers: R-06-101
12208 ( Other Identifier: REB )
Study First Received: April 20, 2009
Last Updated: July 8, 2013

Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Brachial plexus
Ultrasound processed this record on May 25, 2017