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Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Reino Poyhia, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01536717
First received: February 16, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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)


Condition Intervention Phase
Diseases of Mitral Valve
Aortic Valve Disorder
Atrial Septal Defects
Intracardiac Myxoma
Drug: Articaine hydrochloride 2% solution
Drug: Sodium Chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Oxycodone consumption [ Time Frame: 72 hours from initiation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of pain in rest/in movement (AUC) [ Time Frame: 72 hours from initiation of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 4 ml/h periosteal wound infusion
  • duration of 72 h
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%

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective procedure
  • open heart surgery
  • aortic valve surgery
  • mitral valve surgery
  • atrial septal defect repair surgery
  • intracardial myxoma removal surgery

Exclusion Criteria:

  • local anesthetic allergy
  • sulphide allergy
  • asthma
  • pregnant women
  • neurological disease (TIA excluded)
  • congestive heart failure
  • left ventricle ejection fracture under 0.3
  • liver failure
  • diabetes mellitus with documented polyneuropathy
  • chronic pain condition
  • mother tongue not finnish or swedish
  • patients, who do not agree blood transfusions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536717

Contacts
Contact: Mihkel Meinberg, MD +358504286766 mihkel.meinberg@hus.fi
Contact: Reino Pöyhiä, MD, PhD +35894711 reino.poyhia@hus.fi

Locations
Finland
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Mihkel Meinberg, MD    +358504286766    mihkel.meinberg@hus.fi   
Contact: Reino Pöyhiä, MD, PhD, Docent    +35894711    reino.poyhia@hus.fi   
Principal Investigator: Mihkel Meinberg, MD         
Sub-Investigator: Pertti Pere, MD, PhD         
Sub-Investigator: Leena Mildh, MD, PhD         
Sub-Investigator: Katri Hamunen, MD, PhD         
Sub-Investigator: Reino Pöyhiä, MD, PhD         
Sub-Investigator: Anne Pesonen, MD, PhD         
Sub-Investigator: Eero Pesonen, MD, PhD         
Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Mihkel Meinberg, MD    +358504286766    mihkel.meinberg@hus.fi   
Contact: Reino Pöyhiä, MD, PhD    +35894711    reino.poyhia@hus.fi   
Sub-Investigator: Pekka Hämmäinen, MD, PhD         
Sub-Investigator: Antti Vento, MD, PhD         
Sub-Investigator: Antero Sahlman, MD         
Sub-Investigator: Leo Ihlberg, MD, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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
  More Information

Publications:

Responsible Party: Reino Poyhia, MD, PhD, Docent, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01536717     History of Changes
Other Study ID Numbers: 2011-004307-20
Study First Received: February 16, 2012
Last Updated: October 8, 2014
Health Authority: Finland: Finnish Medicines Agency
Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
atrial septal defect
mitral valve annuloplasty
aortic valve annuloplasty
open heart surgery
oxycodone consumption
articain
bupivacaine
pain after sternotomy
postoperative pain
wound infusion

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Anesthetics, Local
Bupivacaine
Carticaine
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014