Infraclavicular Brachial Plexus Block Clinical Trial
Official title:
Minimum Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Infraclavicular Block
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for
various surgical procedures on the upper limb. These blocks are performed with the aid of an
ultrasound machine to improve the success rate. Below the clavicle approach to these nerves
is used for surgeries below the elbow, forearm and hand efficiently.
Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread
of the freezing medication (local anesthetic) in real-time therefore reducing complications
and improving success rates of blocks. It may be possible that a smaller volume of local
anesthetic in this setting may allow effective anesthesia while lowering the adverse effects.
The aim of this study is to find out the lowest volume of the local anesthetic that will be
effective in blocking the nerves adequately.
This is a dose finding study. Volume assignment of ropivacaine will be carried out using a
Biased Coin Design up and down method. In this method, the volume of local anesthetic
(ropivacaine) administered to each patient will depends on the response of the previous
patient. In the event of block failure, the next subject will receive an additional 2 mL of
volume compared with the previous patient. In the event of block success, the next patient
will receive either the same volume as the last patient or a 2 mL reduction in volume (per
the biased coin design with a probability of the same volume being 0.9 and lower volume being
0.1). The first patient in the study will receive 30 mL and depending on the block success,
the volume of the next block will be increased or decreased. The biased coin design is well
described and established in other minimum volume studies.
All patients will have the block in the block room with standard monitoring (non-invasive
blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and
fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in
regional anesthesia and who work routinely in the block room or by a resident or fellow who
is directly supervised by one of these staff anesthesiologist.
There will be two follow up telephone call to all patients enrolled in this study 24 hours
post block insertion and one at 7 days to discuss length of block duration, any postoperative
nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block.
The participants will be informed of this phone call as part of the consent process and their
telephone number will be confirmed.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00993746 -
2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula
|
Phase 4 |