Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00724035
First received: July 25, 2008
Last updated: July 14, 2009
Last verified: July 2009

July 25, 2008
July 14, 2009
May 2008
June 2009   (final data collection date for primary outcome measure)
Onset time of brachial plexus sensory block [ Time Frame: q5min up to 30 min after the block ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00724035 on ClinicalTrials.gov Archive Site
  • Onset of brachial plexus motor block [ Time Frame: q5min up to 30 min after the block ] [ Designated as safety issue: No ]
  • Patient satisfaction (3-point scale) [ Time Frame: End of surgery ] [ Designated as safety issue: No ]
  • Anesthesia-related procedural pain (0-10 numerical rating scale) [ Time Frame: End of block placement ] [ Designated as safety issue: No ]
  • Rescue analgesic requirements during surgery [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial

This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.

Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.

The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.

Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.

A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.

The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Upper Extremity
  • Orthopedic Surgery
  • Trauma
  • Forearm Injuries
  • Nerve Block
  • Drug: Midazolam

    Procedural sedation before the execution of the block.

    • 0.03 mg/kg iv bolus
    Other Names:
    • Versed
    • Benzodiazepine
    • Premedication
    • Sedation
  • Drug: Ropivacaine
    0.75% (wt/vol) solution, 20 ml perineural injection
    Other Names:
    • Naropin
    • Local anesthetic
    • Amide local anesthetic
  • Drug: Fentanyl
    50 µg iv bolus prn for pain during surgery, up to 150 µg
    Other Names:
    • Opioid
    • Analgesic
  • Procedure: General anesthesia
    General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
    Other Names:
    • General anesthesia
    • Monitored anesthesia care
  • Procedure: Axillary brachial plexus nerve block

    Blocks will be performed under high-resolution real-time ultrasound guidance.

    Patients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery.

    A 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose.

    Other Names:
    • Peripheral Nerve Block
    • Regional Anesthesia
    • Ultrasound
  • Procedure: Infraclavicular brachial plexus block

    Blocks will be performed under high-resolution real-time ultrasound guidance.

    Patients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane.

    The axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks.

    Other Names:
    • Regional Anesthesia
    • Peripheral nerve block
    • Ultrasound
  • Experimental: Infraclavicular
    This group will receive an ultrasound-guided infraclavicular brachial plexus block.
    Interventions:
    • Drug: Midazolam
    • Drug: Ropivacaine
    • Drug: Fentanyl
    • Procedure: General anesthesia
    • Procedure: Infraclavicular brachial plexus block
  • Active Comparator: Axillary
    This group will receive an ultrasound-guided axillary brachial plexus block.
    Interventions:
    • Drug: Midazolam
    • Drug: Ropivacaine
    • Drug: Fentanyl
    • Procedure: General anesthesia
    • Procedure: Axillary brachial plexus nerve block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA Physical Status Class <4
  • Scheduled upper extremity orthopedic surgery

Exclusion Criteria:

  • Psychiatric or cognitive disorder
  • Allergy to study drugs
  • Contraindication to nerve block at the assigned site
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00724035
ANEST-ORT-02
No
Guido Fanelli, MD, University of Parma
University of Parma
Not Provided
Study Chair: Guido Fanelli, MD Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma
Principal Investigator: Giorgio Danelli, MD UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
University of Parma
July 2009

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