Clinical trial NCT03957772: The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block
Official title: The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Extremity Problem
Keywords: upper extremity surgery
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2019-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: 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

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.

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

Primary outcomes:
measure: Hemidiaphragmatic paresis 30 minutes after the block
timeFrame: 30 minutes after the block
Secondary outcomes:
measure: Hemidiaphragmatic paresis 2 hours after surgery
timeFrame: 2 hours after surgery
measure: Bedside spirometry before the block (baseline)
timeFrame: 30 minutes before the block
measure: Bedside spirometry after 30 minutes after the block
timeFrame: 30 minutes after the supraclavicular block
measure: Bedside spirometry 2 hours after surgery
timeFrame: 2 hours after surgery
measure: Rate of successful block 30 minutes after the block
timeFrame: 30 minutes after the block
measure: Block-related side effects
timeFrame: 24 h postoperatively
measure: Pain during block procedure
timeFrame: During block procedure
measure: Pain at rest and on movement
timeFrame: 24 h postoperatively
measure: Postoperative opioid consumption
timeFrame: 24 hours postoperatively
measure: Patient satisfaction with overall anesthetic management
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hopital du Valais
Study officials:
affiliation: Hôpital du Valais
name: Sina Grape, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grape S, Kirkham K, Zemirline N, Bikfalvi A, Albrecht E. Impact of an extrafascial versus intrafascial injection for supraclavicular brachial plexus block on respiratory function: a randomized, controlled, double-blind trial. Reg Anesth Pain Med. 2022 Oct;47(10):604-609. doi: 10.1136/rapm-2022-103634. Epub 2022 Jul 1.