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Completed

NCT Number: NCT01761175

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de Saint-Sacrement, Québec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided infraclavicular block

Procedure

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 axillary block

Procedure

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. Duration of Surgery

    Time frame: The end of surgery

  10. Tourniquet Use

    Time frame: The end of surgery

    Number of participants who had a tourniquet during the surgery

  11. Duration of Tourniquet

    Time frame: The end of surgery

    The total time the tourniquet was left inflated

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2013
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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