NCT02657291

Brief Summary

Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

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

Study Start

First participant enrolled

December 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

December 10, 2015

Last Update Submit

January 17, 2021

Conditions

Upper Limb Injury

Outcome Measures

Primary Outcomes (1)

  • Block onset time

    From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery

    1 hour

Secondary Outcomes (4)

  • Procedure duration

    1 hour

  • Quality of block

    1 hour

  • Patient satisfaction

    1 day

  • Requirement for supplemental analgesia or anesthesia

    1 day

Study Arms (2)

Costoclavicular

EXPERIMENTAL

Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach

Drug: RopivacaineDevice: Ultrasound

Paracoracoid

ACTIVE COMPARATOR

Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach

Drug: RopivacaineDevice: Ultrasound

Interventions

RopivacaineDRUG

Local anesthetic

Also known as: Naropin
CostoclavicularParacoracoid
UltrasoundDEVICE

Ultrasound guided block

CostoclavicularParacoracoid

Eligibility Criteria

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

You may qualify if:

  • Ambulatory elective surgery of the upper limb
  • ASA (American Society of Anesthesiologists physical status classification system) 1-4
  • Suitable for procedure to be carried out under infraclavicular block

You may not qualify if:

  • Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
  • Ongoing major medical or psychiatric problems
  • Narcotic 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
  • Women of childbearing age who are not taking adequate contraceptive precautions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Related Publications (4)

  • Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

    PMID: 25899958BACKGROUND

  • Bigeleisen P, Wilson M. A comparison of two techniques for ultrasound guided infraclavicular block. Br J Anaesth. 2006 Apr;96(4):502-7. doi: 10.1093/bja/ael024. Epub 2006 Feb 24.

    PMID: 16500953BACKGROUND

  • Mosaffa F, Gharaei B, Rafeeyan M, Gachkar L. Comparing vertical and coracoid approaches for infraclavicular block in orthopedic surgery of the forearm and hand. J Clin Anesth. 2012 May;24(3):196-200. doi: 10.1016/j.jclinane.2011.07.013. Epub 2012 Apr 5.

    PMID: 22484026BACKGROUND

  • Acar S, Gurkan Y, Solak M, Toker K. Coracoid versus lateral sagittal infraclavicular block. Acta Orthop Traumatol Turc. 2013;47(1):32-7. doi: 10.3944/aott.2013.2615.

    PMID: 23549315BACKGROUND

MeSH Terms

Conditions

Arm Injuries

Interventions

RopivacaineUltrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Shalini Dhir

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2015

First Posted

January 15, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

CA(1)