Comparison of the local anaesthetics articaine and bupivacaine in treatment of acute sternum pain after heart surgery

Conditions: Patients undergoing elective open aortic or mitral valve, atrial septal defect or myxoma surgery
MedDRA version: 14.1Level: LLTClassification code 10048935Term: Open heart surgerySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-004307-20-FI

Lead Sponsor: Reino Pöyhiä

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients undergoing elective open aortic or mitral valve, atrial septal defect or myxoma surgery; aged 18-75
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

age over 75, known mental disorder, pregnancy, allergy to local anaesthetics and/or sulphide allergy, renal failure (GFR < 60), neurological disease other than TIA, obstructice pulmonary disease, liver failure, congestive heart failure (LVEF < 0.3), diabetes mellitus type I, patients with chronic pain condition

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of articaine 2% solution with bupivacaine 0.5% solution and placebo in treatment of acute pain after sternotomy;Secondary Objective: Incidence of periosseal and/or subcutaneous infection complications within 6 months postoperatively;Primary end point(s): Consumption of oxycodone during the first 72 hours postoperatively;Timepoint(s) of evaluation of this end point: continuous and cumulative evaluation during the first 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): pain severity at rest and motion/coughing, adverse effects, infections;Timepoint(s) of evaluation of this end point: Consumption of oxycodone and adverse effects during the first 72 hours. Infection incidence during 6 months postoperatively