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

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00724035
First received: July 25, 2008
Last updated: July 14, 2009
Last verified: July 2009
  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:


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 Names:
  • General anesthesia
  • 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 Names:
  • General anesthesia
  • 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
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

No publications provided

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

ClinicalTrials.gov processed this record on July 24, 2014