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

NCT00724035 | Completed Phase 4

• 1 other identifier: ANEST-ORT-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Extremity; Orthopedic Surgery; Trauma; Forearm Injuries; Nerve Block

Keywords

Anesthesia; Upper extremity; Nerve block; Ultrasound; Brachial plexus

Outcome Measures

Primary Outcomes (1)

• Onset time of brachial plexus sensory block

  q5min up to 30 min after the block

Secondary Outcomes (4)

• 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

Study Arms (2)

Infraclavicular

EXPERIMENTAL

This group will receive an ultrasound-guided infraclavicular brachial plexus block.

Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Infraclavicular brachial plexus block

Axillary

ACTIVE COMPARATOR

This group will receive an ultrasound-guided axillary brachial plexus block.

Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Axillary brachial plexus nerve block

Interventions

Midazolam DRUG

Procedural sedation before the execution of the block. * 0.03 mg/kg iv bolus

Also known as: Versed, Benzodiazepine, Premedication, Sedation

Axillary; Infraclavicular

Ropivacaine DRUG

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

Also known as: Naropin, Local anesthetic, Amide local anesthetic

Axillary; Infraclavicular

Fentanyl DRUG

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

Also known as: Opioid, Analgesic

Axillary; Infraclavicular

General anesthesia PROCEDURE

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

Also known as: Monitored anesthesia care

Axillary; Infraclavicular

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.

Also known as: Peripheral Nerve Block, Regional Anesthesia, Ultrasound

Axillary

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.

Also known as: Regional Anesthesia, Peripheral nerve block, Ultrasound

Infraclavicular

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychiatric or cognitive disorder
• Allergy to study drugs
• Contraindication to nerve block at the assigned site

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

Location

MeSH Terms

Conditions

Wounds and Injuries; Forearm Injuries

Interventions

Midazolam; Benzodiazepines; Premedication; Ropivacaine; Anesthetics, Local; Fentanyl; Analgesics, Opioid; Analgesics; Anesthesia, General; Anesthesia, Conduction; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Arm Injuries

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Narcotics; Anesthesia; Anesthesia and Analgesia; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Guido Fanelli, MD

  Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma

  STUDY CHAIR

• Giorgio Danelli, MD

  UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

IT (1)