Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

NCT ID: NCT01136447

Last Updated: 2017-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Disorder of Upper Extremity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neurostimulation

Block catheter will be introduced using neurostimulation

Group Type PLACEBO_COMPARATOR

Ultrasound

Intervention Type PROCEDURE

Block catheter will be introduced using ultraosound

Ultrasound

Block catheter will be introduced using ultrasound

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type PROCEDURE

Block catheter will be introduced using ultraosound

Interventions

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Ultrasound

Block catheter will be introduced using ultraosound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Shalini Dhir

DR.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shalini Dhir, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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St. Joseph's Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12208

Identifier Type: OTHER

Identifier Source: secondary_id

R-06-101

Identifier Type: -

Identifier Source: org_study_id

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