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Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block

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ClinicalTrials.gov Identifier: NCT01761175
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ariane Boivin, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE January 3, 2013
First Posted Date  ICMJE January 4, 2013
Results First Submitted Date  ICMJE March 28, 2014
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Number of Patients With Complete Motor Blocks [ Time Frame: 30 minutes after block completion ]
    Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
  • Time to Complete Sensory Block. [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes after block completion ]
    Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
  • Time to Complete Motor Block [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes after block completion ]
    Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
  • Surgical Block Success Rate [ Time Frame: End of surgery ]
    Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.
  • Performance Time of the Nerve Block [ Time Frame: During the performance of the block ]
    Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).
  • Procedure-related Pain on a Visual Analog Pain Scale [ Time Frame: After the nerve block procedure ended, up to 5 minutes. ]
    Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).
  • Number of Patients With Postoperative Adverse Events Related to Nerve Block [ Time Frame: 24 hours after surgery ]
    Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
  • Number of Patients With Postoperative Adverse Events Related to Nerve Block [ Time Frame: 1 month after surgery ]
    Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
  • Duration of Surgery [ Time Frame: The end of surgery ]
  • Tourniquet Use [ Time Frame: The end of surgery ]
    Number of participants who had a tourniquet during the surgery
  • Duration of Tourniquet [ Time Frame: The end of surgery ]
    The total time the tourniquet was left inflated
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Number of Patients With Complete Motor Blocks [ Time Frame: 30 minutes after block completion ]
    Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
  • Time to complete sensory and motor blocks. [ Time Frame: 0, 5, 10, 15, 20, 25 and 30 minutes after block completion ]
    Sensory and motor blocks are evaluated in the median, ulnar, radial and musculocutaneous nerves territories.
  • Procedure-related Pain on a Visual Analog Pain Scale [ Time Frame: During the nerve block procedure ]
  • Number of patients with adverse events related to nerve block [ Time Frame: 24 hours and 1 month after surgery ]
  • Surgical Block Success Rate [ Time Frame: End of surgery ]
    Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.
  • Performance Time of the Nerve Block [ Time Frame: During the performance of the block ]
    Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block
Official Title  ICMJE Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Procedure: Ultrasound-guided infraclavicular block
    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.
  • Procedure: Ultrasound-guided axillary block
    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.
Study Arms  ICMJE
  • Active Comparator: Ultrasound-guided infraclavicular block
    Ultrasound-guided single injection infraclavicular block
    Intervention: Procedure: Ultrasound-guided infraclavicular block
  • Active Comparator: Ultrasound-guided axillary block
    Ultrasound-guided double injection axillary block
    Intervention: Procedure: Ultrasound-guided axillary block
Publications * Boivin A, Nadeau MJ, Dion N, Lévesque 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
224
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761175
Other Study ID Numbers  ICMJE PEJ-666
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ariane Boivin, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP