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Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

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ClinicalTrials.gov Identifier: NCT01136447
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : August 30, 2017
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment
Disorder of Upper Extremity Procedure: Ultrasound

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement
Study Start Date : January 2010
Primary Completion Date : January 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Neurostimulation versus ultrasound guided infraclavicular catheter placement [ Time Frame: 14 days ]
    Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters

Secondary Outcome Measures :
  1. Time taken for complete nerve block [ Time Frame: 14 days ]
    Procedure time for both techniques

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shalini Dhir, DR., Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01136447     History of Changes
Other Study ID Numbers: R-06-101
12208 ( Other Identifier: REB )
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Brachial plexus