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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-04-30

Brief Summary

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Patients will be randomized to one of two groups:

1. 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
2. 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

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Detailed Description

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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.

Conditions

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Upper Extremity Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The participants and all care providers will be blinded to the patient assignment.

Study Groups

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Extrafascial injection

Extrafascial injection of local anesthetic

Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic

Group Type ACTIVE_COMPARATOR

Extrafascial injection

Intervention Type PROCEDURE

Extrafascial injection of local anaesthetic under ultrasound guidance

Intrafascial injection

Intrafascial injection of local anesthetic

Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic

Group Type EXPERIMENTAL

Intrafascial injection

Intervention Type PROCEDURE

Intrafascial injection of local anaesthetic under ultrasound guidance

Interventions

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Extrafascial injection

Extrafascial injection of local anaesthetic under ultrasound guidance

Intervention Type PROCEDURE

Intrafascial injection

Intrafascial injection of local anaesthetic under ultrasound guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No