Arthritis Clinical Trial
Official title:
Improving the Success Rate of Continuous Peripheral Nerve Blocks Using a Novel Coiled Catheter
Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic
therapy. The successful use of continuous peripheral nerve blocks provides sustained
analgesia while minimizing the need for opioid analgesics throughout the postoperative
period and avoiding the side effects associated with central neuraxial techniques. Excellent
analgesia can be maintained and opioid-related side effects avoided allowing improved
rehabilitation. However using existing methods a failure rate of >20% significantly limits
the analgesic benefits in a substantial proportion leading to uncontrolled pain and side
effects of opioid analgesics.
A major concern with the use of continuous peripheral nerve blocks is difficulty in
placement of the catheters close enough to the nerve to allow for effective local
anaesthetic spread and therefore analgesia. The benefit of ultrasound to precisely place
needles adjacent to nerves and increase efficacy of block success is undisputed. However
ultrasound is of less help in accurately placing catheters. Indeed the final position of the
catheter tip is not predictable and can be inadequate in 10%-50% of cases. The explanation
for that is the material in currently used catheters is stiff and designed to avoid kinking.
Unfortunately this same stiffness often leads to inadequate placement of the catheter tip.
We have developed a catheter which coils up as soon as it is advanced beyond the needle tip,
thus allowing the catheter tip to remain close to the initial needle tip position and
therefore the nerve. The aim of this prospective randomized double blind controlled study is
to determine the effectiveness of this new catheter in comparison with standard of care
methods for continuous femoral nerve block commonly used after total knee arthroplasty. The
primary outcome measure will be the incidence of catheter related block failure 24 hours
after surgery. Our hypothesis is that the coiled catheter will significantly improve the
efficacy of continuous femoral nerve block as compared to existing techniques.
Aims of the study The aim is to determine the effectiveness of a the coiled catheter for
continuous peripheral nerve block after total knee arthroplasty based on secondary block
failures compared to the secondary block failures of the conventional, currently used
stimulating catheters.
Study design The trial is a prospective single-centre randomized double-blinded controlled
trial. Patients will be randomized to (1) use of conventional stimulating catheters or (2)
to use of a coiled catheter.
Patient population Adult patients of at least 18 years of age undergoing unilateral knee
arthroplasty, under spinal anaesthesia will be recruited in this randomized double blind
controlled trial.
Inclusion criteria: Ability to provide informed consent, understanding of the possible local
anaesthetic-related complications, and understanding of the study protocol.
Exclusion criteria: Any contraindication to peripheral nerve block, allergy to local
anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy,
chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known
hepatic or renal insufficiency, peripheral neuropathy and patient refusal.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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