The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block
- Conditions
- Upper Extremity Problem
- Interventions
- Procedure: Extrafascial injectionProcedure: Intrafascial injection
- Registration Number
- NCT03957772
- Lead Sponsor
- Hôpital du Valais
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients undergoing forearm or hand surgery under locoregional anesthesia
- ASA physical status I-III
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extrafascial injection Extrafascial injection Extrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic Intrafascial injection Intrafascial injection Intrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Block-related side effects 24 h postoperatively paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection
Bedside spirometry before the block (baseline) 30 minutes before the block Bedside spirometry before the supraclavicular block
Pain during block procedure During block procedure Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)
Hemidiaphragmatic paresis 2 hours after surgery 2 hours after surgery Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound
Postoperative opioid consumption 24 hours postoperatively Cumulative postoperative opioid consumption
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
Bedside spirometry after 30 minutes after the block 30 minutes after the supraclavicular block Bedside spirometry after the supraclavicular block
Pain at rest and on movement 24 h postoperatively Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)
Patient satisfaction with overall anesthetic management 24 hours postoperatively numeric rating scale, 0-10)
Trial Locations
- Locations (1)
Hopital du Valais
🇨🇭Sion, Switzerland