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

Phase 4

Completed

• Conditions: Upper Extremity; Orthopedic Surgery; Trauma; Forearm Injuries; Nerve Block
• Interventions: Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Infraclavicular brachial plexus block; Procedure: Axillary brachial plexus nerve block

• Registration Number: NCT00724035
• Lead Sponsor: University of Parma

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.

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-06
• Status Verified: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infraclavicular	General anesthesia	This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Infraclavicular	Infraclavicular brachial plexus block	This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Axillary	Ropivacaine	This group will receive an ultrasound-guided axillary brachial plexus block.
Axillary	General anesthesia	This group will receive an ultrasound-guided axillary brachial plexus block.
Axillary	Axillary brachial plexus nerve block	This group will receive an ultrasound-guided axillary brachial plexus block.
Infraclavicular	Midazolam	This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Infraclavicular	Ropivacaine	This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Infraclavicular	Fentanyl	This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Axillary	Midazolam	This group will receive an ultrasound-guided axillary brachial plexus block.
Axillary	Fentanyl	This group will receive an ultrasound-guided axillary brachial plexus block.

Primary Outcome Measures

Name	Time	Method
Onset time of brachial plexus sensory block	q5min up to 30 min after the block

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital / Azienda Ospedaliero-Universitaria; 🇮🇹 Parma, PR, Italy