Upper Extremity Problem
Conditions
Keywords
upper extremity surgery
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.
Interventions
PROCEDUREExtrafascial injection
Extrafascial injection of local anaesthetic under ultrasound guidance
PROCEDUREIntrafascial injection
Intrafascial injection of local anaesthetic under ultrasound guidance
Sponsors
University of Lausanne Hospitals
Hôpital du Valais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participants and all care providers will be blinded to the patient assignment.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemidiaphragmatic paresis 30 minutes after the block | 30 minutes after the block | Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bedside spirometry before the block (baseline) | 30 minutes before the block | Bedside spirometry before the supraclavicular block |
| Bedside spirometry after 30 minutes after the block | 30 minutes after the supraclavicular block | Bedside spirometry after the supraclavicular block |
| Bedside spirometry 2 hours after surgery | 2 hours after surgery | Bedside spirometry 2 hours after surgery |
| Rate of successful block 30 minutes after the block | 30 minutes after the block | Presence of a surgical block according to a validated composite scale |
| Hemidiaphragmatic paresis 2 hours after surgery | 2 hours after surgery | Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound |
| Pain during block procedure | During block procedure | Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain) |
| Pain at rest and on movement | 24 h postoperatively | Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain) |
| Postoperative opioid consumption | 24 hours postoperatively | Cumulative postoperative opioid consumption |
| Patient satisfaction with overall anesthetic management | 24 hours postoperatively | numeric rating scale, 0-10) |
| Block-related side effects | 24 h postoperatively | paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection |
Countries
Switzerland
Outcome results
None listed