NCT01136447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

April 20, 2009

Last Update Submit

August 29, 2017

Conditions

Disorder of Upper Extremity

Keywords

Brachial plexusUltrasound

Outcome Measures

Primary Outcomes (1)

  • Neurostimulation versus ultrasound guided infraclavicular catheter placement

    Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters

    14 days

Secondary Outcomes (1)

  • Time taken for complete nerve block

    14 days

Study Arms (2)

Neurostimulation

PLACEBO COMPARATOR

Block catheter will be introduced using neurostimulation

Procedure: Ultrasound

Ultrasound

ACTIVE COMPARATOR

Block catheter will be introduced using ultrasound

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

Block catheter will be introduced using ultraosound

NeurostimulationUltrasound

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Shalini Dhir, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

April 20, 2009

First Posted

June 3, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

CA(1)