Major Ankle Surgery Clinical Trial
Official title:
A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major ankle surgery is infusion of local
analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified
in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve
catheter provide a better treatment of pain in comparison with a single injection nerve
block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a
preliminary analysis of the data from the first 40 patients. However, it is not an interim
analysis. Fifty patients will be included independent of the result of the preliminary
analysis. The random allocation of the last 10 patients will also be double-blinded.
Major ankle surgery are known to be very painful the first 48 hours after the operation due
to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief
with systemic analgesics requires high doses of intravenous opioids and is associated with
breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation,
urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need
for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard
pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate
placement of the catheter many patients are in great pain because the saphenous nerve remain
unaffected. A single injection block relieve the pain but a block with Ropivacaine only last
8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea,
vomiting, reduced ambulation, increased surgical stress response and increased morbidity.
Pain problems and adverse effects prolongs postoperative observation time and maybe also
time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain
relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared
with single injection block.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment