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

NCT01536717 | Suspended Phase 4

• 1 other identifier: 2011-004307-20
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Diseases of Mitral Valve; Aortic Valve Disorder; Atrial Septal Defects; Intracardiac Myxoma

Keywords

atrial septal defect; mitral valve annuloplasty; aortic valve annuloplasty; open heart surgery; oxycodone consumption; articain; bupivacaine; pain after sternotomy; postoperative pain; wound infusion

Outcome Measures

Primary Outcomes (1)

• Oxycodone consumption

  72 hours from initiation of treatment

Secondary Outcomes (1)

• Intensity of pain in rest/in movement (AUC)

  72 hours from initiation of treatment

Study Arms (2)

Bupivacaine hydrochloride 0.5%

ACTIVE COMPARATOR

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

Sodium chloride 0,9%

PLACEBO COMPARATOR

Drug: Sodium Chloride

Interventions

Articaine hydrochloride 2% solution DRUG

* 4 ml/h periosteal wound infusion * duration of 72 h

Also known as: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

Bupivacaine hydrochloride 0.5%

Sodium Chloride DRUG

Placebo Sodium chloride 0,9%

Sodium chloride 0,9%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (20)

• Kehlet H, Andersen LO. Local infiltration analgesia in joint replacement: the evidence and recommendations for clinical practice. Acta Anaesthesiol Scand. 2011 Aug;55(7):778-84. doi: 10.1111/j.1399-6576.2011.02429.x. Epub 2011 Apr 4.

  PMID: 21463261 BACKGROUND

• White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.

  PMID: 14508326 BACKGROUND

• Magnano D, Montalbano R, Lamarra M, Ferri F, Lorini L, Clarizia S, Rescigno G. Ineffectiveness of local wound anesthesia to reduce postoperative pain after median sternotomy. J Card Surg. 2005 Jul-Aug;20(4):314-8. doi: 10.1111/j.1540-8191.2005.200318.x.

  PMID: 15985128 BACKGROUND

• Pere P, Lindgren L, Vaara M. Poor antibacterial effect of ropivacaine: comparison with bupivacaine. Anesthesiology. 1999 Sep;91(3):884-6. doi: 10.1097/00000542-199909000-00047. No abstract available.

  PMID: 10485806 BACKGROUND

• Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.

  PMID: 15966499 BACKGROUND

• Pelz K, Wiedmann-Al-Ahmad M, Bogdan C, Otten JE. Analysis of the antimicrobial activity of local anaesthetics used for dental analgesia. J Med Microbiol. 2008 Jan;57(Pt 1):88-94. doi: 10.1099/jmm.0.47339-0.

  PMID: 18065672 BACKGROUND

• Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4. doi: 10.1016/s0378-4347(00)81126-3. No abstract available.

  PMID: 3372637 BACKGROUND

• Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16. doi: 10.1111/j.1399-6576.1977.tb01186.x.

  PMID: 320810 BACKGROUND

• Kallio H, Snall EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. doi: 10.1093/bja/ael222. Epub 2006 Aug 5.

  PMID: 16891634 BACKGROUND

• Pitkanen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5.

  PMID: 10204898 BACKGROUND

• Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607.

  PMID: 10599952 BACKGROUND

• Trullenque-Eriksson A, Guisado-Moya B. Comparative study of two local anesthetics in the surgical extraction of mandibular third molars: bupivacaine and articaine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e390-6. doi: 10.4317/medoral.16.e390.

  PMID: 21196829 BACKGROUND

• Pesonen A, Suojaranta-Ylinen R, Hammaren E, Kontinen VK, Raivio P, Tarkkila P, Rosenberg PH. Pregabalin has an opioid-sparing effect in elderly patients after cardiac surgery: a randomized placebo-controlled trial. Br J Anaesth. 2011 Jun;106(6):873-81. doi: 10.1093/bja/aer083. Epub 2011 Apr 6.

  PMID: 21474474 BACKGROUND

• Hillerup S, Bakke M, Larsen JO, Thomsen CE, Gerds TA. Concentration-dependent neurotoxicity of articaine: an electrophysiological and stereological study of the rat sciatic nerve. Anesth Analg. 2011 Jun;112(6):1330-8. doi: 10.1213/ANE.0b013e3182172a2e. Epub 2011 Apr 5.

  PMID: 21467556 BACKGROUND

• Tirotta CF, Munro HM, Salvaggio J, Madril D, Felix DE, Rusinowski L, Tyler C, Decampli W, Hannan RL, Burke RP. Continuous incisional infusion of local anesthetic in pediatric patients following open heart surgery. Paediatr Anaesth. 2009 Jun;19(6):571-6. doi: 10.1111/j.1460-9592.2009.03009.x.

  PMID: 19645974 BACKGROUND

• Hynninen MS, Cheng DC, Hossain I, Carroll J, Aumbhagavan SS, Yue R, Karski JM. Non-steroidal anti-inflammatory drugs in treatment of postoperative pain after cardiac surgery. Can J Anaesth. 2000 Dec;47(12):1182-7. doi: 10.1007/BF03019866.

  PMID: 11132739 BACKGROUND

• Lahtinen P, Kokki H, Hendolin H, Hakala T, Hynynen M. Propacetamol as adjunctive treatment for postoperative pain after cardiac surgery. Anesth Analg. 2002 Oct;95(4):813-9, table of contents. doi: 10.1097/00000539-200210000-00005.

  PMID: 12351250 BACKGROUND

• Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.

  PMID: 10936130 BACKGROUND

• Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. doi: 10.2165/00003088-199733060-00002.

  PMID: 9435991 BACKGROUND

• Simon MA, Vree TB, Gielen MJ, Booij LH. Comparison of the effects and disposition kinetics of articaine and lidocaine in 20 patients undergoing intravenous regional anaesthesia during day case surgery. Pharm World Sci. 1998 Apr;20(2):88-92. doi: 10.1023/a:1008622018161.

  PMID: 9584343 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Disease; Heart Septal Defects, Atrial; Atrial myxoma, familial; Pain, Postoperative

Interventions

Carticaine; Solutions; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Reino Pöyhiä, MD, PhD

  Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

  STUDY CHAIR

• Mihkel Meinberg, MD

  Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Docent

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

FI (2)