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.

Study Overview

• Status: Completed
• Conditions: Trauma; Forearm Injuries; Orthopedic Surgery; Nerve Block; Upper Extremity
• Intervention / Treatment: Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Infraclavicular brachial plexus block; Procedure: Axillary brachial plexus nerve block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • PR
    • Parma, PR, Italy, 43100
      • University Hospital / Azienda Ospedaliero-Universitaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Infraclavicular; This group will receive an ultrasound-guided infraclavicular brachial plexus block.	Drug: Midazolam; Procedural sedation before the execution of the block.; 0.03 mg/kg iv bolus; Other Names: Versed; Premedication; Sedation; Benzodiazepine; 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: Monitored anesthesia care; 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: Ultrasound; Peripheral nerve block; Regional Anesthesia
ACTIVE_COMPARATOR: Axillary; This group will receive an ultrasound-guided axillary brachial plexus block.	Drug: Midazolam; Procedural sedation before the execution of the block.; 0.03 mg/kg iv bolus; Other Names: Versed; Premedication; Sedation; Benzodiazepine; 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: 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: Ultrasound; Peripheral Nerve Block; Regional Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Onset time of brachial plexus sensory block	q5min up to 30 min after the block

Secondary Outcome Measures

Outcome Measure	Time Frame
Onset of brachial plexus motor block	q5min up to 30 min after the block
Patient satisfaction (3-point scale)	End of surgery
Anesthesia-related procedural pain (0-10 numerical rating scale)	End of block placement
Rescue analgesic requirements during surgery	During surgery

Collaborators and Investigators

• Sponsor: University of Parma
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (ESTIMATE): July 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2009
• Last Update Submitted That Met QC Criteria: July 14, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Ultrasound; Upper extremity; Anesthesia; Nerve block; Brachial plexus
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics; Fentanyl; Midazolam; Anesthetics, Local; Ropivacaine; Analgesics
• Other Study ID Numbers: ANEST-ORT-02