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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ariane Boivin, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01761175
First received: January 3, 2013
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Anesthesia Procedure: Ultrasound-guided infraclavicular block Procedure: Ultrasound-guided axillary block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial

Resource links provided by NLM:


Further study details as provided by Ariane Boivin, Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 224
Study Start Date: September 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound-guided infraclavicular block
Ultrasound-guided single injection infraclavicular block
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.
Active Comparator: Ultrasound-guided axillary block
Ultrasound-guided double injection axillary block
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761175

Locations
Canada
Hôpital de l'Enfant-Jésus
Québec, Canada, G1J 1Z4
Hôpital de Saint-Sacrement
Québec, Canada, G1S 4L8
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ariane Boivin, MD, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01761175     History of Changes
Other Study ID Numbers: PEJ-666
Study First Received: January 3, 2013
Results First Received: March 28, 2014
Last Updated: April 25, 2017

ClinicalTrials.gov processed this record on August 18, 2017