The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
Patients will be randomized to one of two groups: Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves

Detailed Description
-----------------
The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups. The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves. The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves. All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management. These outcomes are further defined in the section below.

Official Title
-----------------
The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial

Conditions
-----------------
Upper Extremity Problem

Intervention / Treatment
-----------------
* Procedure: Extrafascial injection
* Procedure: Intrafascial injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing forearm or hand surgery under locoregional anesthesia ASA physical status I-III Exclusion Criteria: Patient refusal ASA physical status IV Severe pre-existing lung disease Patient unwilling or unable to perform incentive spirometry Local anesthetic intolerance or allergy Neurological deficit or neuropathy of the arm Coagulopathy contraindicating locoregional anesthesia Malignancy or infection in the area above the clavicle Pregnancy Inability to understand the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extrafascial injection<br>Extrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic | Procedure: Extrafascial injection<br>* Extrafascial injection of local anaesthetic under ultrasound guidance<br>|
| Experimental: Intrafascial injection<br>Intrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic | Procedure: Intrafascial injection<br>* Intrafascial injection of local anaesthetic under ultrasound guidance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemidiaphragmatic paresis 30 minutes after the block | Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound | 30 minutes after the block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemidiaphragmatic paresis 2 hours after surgery | Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound | 2 hours after surgery | 
| Bedside spirometry before the block (baseline) | Bedside spirometry before the supraclavicular block | 30 minutes before the block | 
| Bedside spirometry after 30 minutes after the block | Bedside spirometry after the supraclavicular block | 30 minutes after the supraclavicular block | 
| Bedside spirometry 2 hours after surgery | Bedside spirometry 2 hours after surgery | 2 hours after surgery | 
| Rate of successful block 30 minutes after the block | Presence of a surgical block according to a validated composite scale | 30 minutes after the block | 
| Block-related side effects | paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection | 24 h postoperatively | 
| Pain during block procedure | Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain) | During block procedure | 
| Pain at rest and on movement | Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain) | 24 h postoperatively | 
| Postoperative opioid consumption | Cumulative postoperative opioid consumption | 24 hours postoperatively | 
| Patient satisfaction with overall anesthetic management | numeric rating scale, 0-10) | 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper extremity surgery