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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
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Patients will be randomized to one of two groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extrafascial injection | Active Comparator | Extrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic |
|
| Intrafascial injection | Experimental | Intrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extrafascial injection | Procedure | Extrafascial injection of local anaesthetic under ultrasound guidance |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sina Grape, MD | Hôpital du Valais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital du Valais | Sion | 1950 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35777931 | Derived | 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. |
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no sharing of any IPD
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Parallel assignment
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The participants and all care providers will be blinded to the patient assignment.
| Intrafascial injection | Procedure | Intrafascial injection of local anaesthetic under ultrasound guidance |
|
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 |