NCT01761175

Brief Summary

The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

January 3, 2013

Results QC Date

March 28, 2014

Last Update Submit

April 25, 2017

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Complete Sensory Block

    Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.

    30 minutes after block completion

Secondary Outcomes (11)

  • Number of Patients With Complete Motor Blocks

    30 minutes after block completion

  • Time to Complete Sensory Block.

    5, 10, 15, 20, 25 and 30 minutes after block completion

  • Time to Complete Motor Block

    5, 10, 15, 20, 25 and 30 minutes after block completion

  • Surgical Block Success Rate

    End of surgery

  • Performance Time of the Nerve Block

    During the performance of the block

  • +6 more secondary outcomes

Study Arms (2)

Ultrasound-guided infraclavicular block

ACTIVE COMPARATOR

Ultrasound-guided single injection infraclavicular block

Procedure: Ultrasound-guided infraclavicular block

Ultrasound-guided axillary block

ACTIVE COMPARATOR

Ultrasound-guided double injection axillary block

Procedure: Ultrasound-guided axillary block

Interventions

Ultrasound-guided infraclavicular blockPROCEDURE

Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery.

Ultrasound-guided infraclavicular block
Ultrasound-guided axillary blockPROCEDURE

Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve.

Ultrasound-guided axillary block

Eligibility Criteria

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

You may qualify if:

  • years or older
  • American Society of Anesthesiologists Class 1 to 3
  • Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia

You may not qualify if:

  • Age less than 18 years
  • Body mass index more than 40 kg/m2
  • Weight less than 45 kg
  • Patient refusal
  • Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)
  • Previous neurological deficit in the operated arm
  • Severe renal or hepatic failure
  • Prior surgery in the axillary or infraclavicular area
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital de l'Enfant-Jésus

Québec, G1J 1Z4, Canada

Location

Hôpital de Saint-Sacrement

Québec, G1S 4L8, Canada

Location

Related Publications (1)

  • Boivin A, Nadeau MJ, Dion N, Levesque S, Nicole PC, Turgeon AF. Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial. Anesth Analg. 2016 Jan;122(1):273-8. doi: 10.1213/ANE.0000000000001017.

    PMID: 26516803DERIVED

Results Point of Contact

Title
Dre Marie-Josée Nadeau
Organization
CHU de Québec, Département d'Anesthésie-Réanimation de l'Hôpital de l'Enfant-Jésus
marie-josee.nadeau@fmed.ulaval.ca
418 649-5807

Study Officials

  • Ariane Boivin, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Marie-Josée Nadeau, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Nicolas Dion, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Simon Lévesque, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Pierre C. Nicole, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Alexis F. Turgeon, MD, Msc

    CHU de Québec

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
MD

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

August 4, 2017

Results First Posted

August 4, 2017

Record last verified: 2017-04

Locations

CA(2)