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

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

Drug Information available for: Fentanyl Fentanyl citrate Midazolam maleate Midazolam hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by University of Parma:

Primary Outcome Measures:

Onset time of brachial plexus sensory block [ Time Frame: q5min up to 30 min after the block ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	52
Study Start Date:	May 2008
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724035

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


Responsible Party:	Guido Fanelli, MD, University of Parma
ClinicalTrials.gov Identifier:	NCT00724035 History of Changes
Other Study ID Numbers:	ANEST-ORT-02
Study First Received:	July 25, 2008
Last Updated:	July 14, 2009
Health Authority:	Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 28, 2016