Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
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|ClinicalTrials.gov Identifier: NCT01536717|
Recruitment Status : Terminated (Withdrawal of principal investigator from clinical duties and organisational reasons)
First Posted : February 22, 2012
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diseases of Mitral Valve Aortic Valve Disorder Atrial Septal Defects Intracardiac Myxoma||Drug: Articaine hydrochloride 2% solution Drug: Sodium Chloride||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Active Comparator: Bupivacaine hydrochloride 0.5%
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
Other Name: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
|Placebo Comparator: Sodium chloride 0,9%||
Drug: Sodium Chloride
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536717
|Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital|
|Helsinki, Uusimaa, Finland, 00029|
|Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital|
|Helsinki, Uusimaa, Finland, 00029|
|Study Chair:||Reino Pöyhiä, MD, PhD||Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital|
|Principal Investigator:||Mihkel Meinberg, MD||Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital|