A Phase 4 interventional study of Articaine hydrochloride 2% solution and Sodium Chloride in Diseases of Mitral Valve, Aortic Valve Disorder and Atrial Septal Defects, sponsored by Helsinki University Central Hospital. Suspended at 2 sites in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment
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
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Drug: Articaine hydrochloride 2% solution
Drug: Sodium Chloride
* 4 ml/h periosteal wound infusion * duration of 72 h
Also known as: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Placebo Sodium chloride 0,9%
Oxycodone consumption
Time frame: 72 hours from initiation of treatment
Intensity of pain in rest/in movement (AUC)
Time frame: 72 hours from initiation of treatment
This study is suspended, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital