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NCT Number: NCT00724035

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

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.

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Key information

Conditions

Upper Extremity Arm Injuries Forearm Injuries Nerve Block Orthopedic Surgery Trauma Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

midazolam

Drug

Procedural sedation before the execution of the block.

  • 0.03 mg/kg iv bolus

Other names: Versed, Benzodiazepine, Premedication, Sedation

Ropivacaine

Drug

0.75% (wt/vol) solution, 20 ml perineural injection

Other names: Naropin, Local anesthetic, Amide local anesthetic

Fentanyl

Drug

50 µg iv bolus prn for pain during surgery, up to 150 µg

Other names: Opioid, Analgesic

General Anesthesia

Procedure

General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.

Other names: Monitored anesthesia care

Axillary brachial plexus nerve block

Procedure

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

Infraclavicular brachial plexus block

Procedure

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

Primary outcomes

  1. Onset time of brachial plexus sensory block

    Time frame: q5min up to 30 min after the block

Secondary outcomes

  1. Onset of brachial plexus motor block

    Time frame: q5min up to 30 min after the block

  2. Patient satisfaction (3-point scale)

    Time frame: End of surgery

  3. Anesthesia-related procedural pain (0-10 numerical rating scale)

    Time frame: End of block placement

  4. Rescue analgesic requirements during surgery

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2008
Registry last updated
Jul 15, 2009

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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