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

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

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

Study Overview

• Status: Completed
• Conditions: Upper Extremity Problem
• Intervention / Treatment: Procedure: Extrafascial injection; Procedure: Intrafascial injection

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Sion, Switzerland, 1950
    • Hopital du Valais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Extrafascial injection; Extrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic	Procedure: Extrafascial injection; Extrafascial injection of local anaesthetic under ultrasound guidance
EXPERIMENTAL: Intrafascial injection; Intrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic	Procedure: Intrafascial injection; Intrafascial injection of local anaesthetic under ultrasound guidance

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

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Collaborators: University of Lausanne Hospitals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (ACTUAL): May 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: upper extremity surgery
• Other Study ID Numbers: 2019 SUPRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no sharing of any IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No