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Clinical Trials/NCT01761175
NCT01761175
Completed
Not Applicable

Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial

CHU de Quebec-Universite Laval2 sites in 1 country224 target enrollmentSeptember 2012
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
CHU de Quebec-Universite Laval
Enrollment
224
Locations
2
Primary Endpoint
Number of Patients With Complete Sensory Block
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
March 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

Ariane Boivin

MD

CHU de Quebec-Universite Laval

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of Patients With Complete Sensory Block

Time Frame: 30 minutes after block completion

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

Secondary Outcomes

  • Procedure-related Pain on a Visual Analog Pain Scale(After the nerve block procedure ended, up to 5 minutes.)
  • Number of Patients With Postoperative Adverse Events Related to Nerve Block(1 month after surgery)
  • 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)
  • Duration of Surgery(The end of surgery)
  • Tourniquet Use(The end of surgery)
  • Duration of Tourniquet(The end of surgery)

Study Sites (2)

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