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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Upper Extremity; Orthopedic Surgery; Trauma; Forearm Injuries; Nerve Block	Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Axillary brachial plexus nerve block; Procedure: Infraclavicular brachial plexus block	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	52 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
Study Start Date :	May 2008
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	July 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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; 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 Name: 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: Regional Anesthesia; Peripheral nerve block; Ultrasound
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; 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 Name: 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

Outcome Measures

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Primary Outcome Measures :

1. Onset time of brachial plexus sensory block [ Time Frame: q5min up to 30 min after the block ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Guido Fanelli, MD, University of Parma
ClinicalTrials.gov Identifier:	NCT00724035 History of Changes
Other Study ID Numbers:	ANEST-ORT-02
First Posted:	July 29, 2008
Last Update Posted:	July 15, 2009
Last Verified:	July 2009

Keywords provided by University of Parma:

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

Additional relevant MeSH terms:

Forearm Injuries; Arm Injuries; Wounds and Injuries; Anesthetics; Fentanyl; Ropivacaine; Midazolam; Anesthetics, Local; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Opioid; Narcotics; Analgesics	Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action