Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01136447
First received: April 20, 2009
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 Lawson Health Research Institute:

Primary Outcome Measures:
  • Neurostimulation versus ultrasound guided infraclavicular catheter placement [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time taken for complete nerve block [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136447

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

No publications provided

Responsible Party: Shalini Dhir, DR., Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01136447     History of Changes
Other Study ID Numbers: R-06-101, 12208
Study First Received: April 20, 2009
Last Updated: July 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Brachial plexus
Ultrasound

ClinicalTrials.gov processed this record on September 30, 2014