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

Trauma Clinical Trial

Official title:

Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724035
• Other study ID #: ANEST-ORT-02
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: July 14, 2009
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Midazolam
Procedural sedation before the execution of the block. 0.03 mg/kg iv bolus
• Ropivacaine
0.75% (wt/vol) solution, 20 ml perineural injection
• Fentanyl
50 µg iv bolus prn for pain during surgery, up to 150 µg

Procedure:
• General anesthesia
General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl =150 µg.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	University Hospital / Azienda Ospedaliero-Universitaria	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time of brachial plexus sensory block		q5min up to 30 min after the block	No
Secondary	Onset of brachial plexus motor block		q5min up to 30 min after the block	No
Secondary	Patient satisfaction (3-point scale)		End of surgery	No
Secondary	Anesthesia-related procedural pain (0-10 numerical rating scale)		End of block placement	No
Secondary	Rescue analgesic requirements during surgery		During surgery	No