Aortic Valve Disorder Clinical Trial
Official title:
Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
Acute pain after open heart surgery can be moderate or strong and is mostly caused by
sternotomy. Pain is the worst during the first two post-operative days and, if not adequately
treated, can delay the patient´s recovery from surgery. Sternotomy pain can be alleviated by
using paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. All these
drugs may have remarkable side-effects which may delay the recovery from surgery: opioids are
respiratory depressants and slower the gastrointestinal motility, NSAIDs reduce intrarenal
blood flow and may disturb coagulation. Post-operative opioid consumption can be reduced by
using wound infiltration analgesia.
The use of wound infiltration analgesia has not been extensively investigated in treatment of
acute pain after sternotomy. There is some evidence, that 0.5% bupivacaine reduces the acute
post-sternotomy pain when infused constantly via catheters placed under the fascia
(periosteal placement) and the skin.
During 48 hours infusion toxic bupivacaine plasma levels were not observed. There is an
evidence that local anesthetics can be bacteriostatic both in vitro and in vivo.
Articaine is an amide-type local anesthetics, which has been used extensively in dental
procedures since more than forty years. It has been successfully used in infiltration,
epidural, spinal and other regional anesthesia procedures. Articaine is quickly hydrolyzed in
plasma and excreted by kidneys. Clearance of articain (500-1110l/h) is faster than that of
lidocaine (68l/h) and it is also the reason for articaine´s low toxicity profile. Because of
it´s low toxicity and high ability to penetrate the periosteal tissue, articaine may be
advantageous in treatment of acute pain after sternotomy, but aforementioned indication for
use of articaine has not been investigated. Compared to other local anesthetics, articaine in
high concentration has the same neurotoxicity profile, when injected directly into rat´s
sciatic nerve. Articaine has not been extensively compared to other local anesthetics, but
according the latest odontologic investigation, single dose 0.5% bupivacaine and single-dose
4% articaine were comparable in their analgesic effects during tooth extraction procedure.
There are no controlled randomized trials comparing analgesic effect of articaine and other
local anesthetics infusions.
In our investigation bupivacain 0.5 % was chosen as an active control, because it has
appeared effective in acute postoperative pain and it has reduced the need for opioid
analgetics after sternotomy
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