Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

August 29, 2017 updated by: Shalini Dhir, Lawson Health Research Institute

Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurostimulation versus ultrasound guided infraclavicular catheter placement
Time Frame: 14 days
Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken for complete nerve block
Time Frame: 14 days
Procedure time for both techniques
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Shalini Dhir, MD, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-06-101
  • 12208 (REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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