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

Upper Extremity Problem Clinical Trial

— SUPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957772
• Other study ID #: 2019 SUPRA
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Hôpital du Valais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Upper Extremity Problem

Intervention

Procedure:
• Extrafascial injection
Extrafascial injection of local anaesthetic under ultrasound guidance
• Intrafascial injection
Intrafascial injection of local anaesthetic under ultrasound guidance

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Sion

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital du Valais	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

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