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

This study has been terminated.
(Withdrawal of principal investigator from clinical duties and organisational reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536717
First Posted: February 22, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reino Poyhia, Helsinki University Central Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Reino Poyhia, Helsinki University Central Hospital:

Primary Outcome Measures:
  • Oxycodone consumption [ Time Frame: 72 hours from initiation of treatment ]

Secondary Outcome Measures:
  • Intensity of pain in rest/in movement (AUC) [ Time Frame: 72 hours from initiation of treatment ]

Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
Finland
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
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
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Reino Poyhia, 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 Septal Defects
Heart Septal Defects, Atrial
Heart Valve Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Bupivacaine
Anesthetics, Local
Carticaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents