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

Comparison of periosteal and subcutaneous infusions of articaine and bupivacaine in treatment of acute pain after sternotomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004307-20-FI

Enrollment

Registered

2012-02-01

Start date

2012-02-09

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing elective open aortic or mitral valve, atrial septal defect or myxoma surgery MedDRA version: 14.1 Level: LLT Classification code 10048935 Term: Open heart surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Bicain 5 mg/ml ® Pharmaceutical Form: Injection CAS Number: 14252-80-3 Other descriptive name: BUPIVACAINE HYDROCHLORIDE MONOHYDRATE Pharmaceutical form of the placebo: Injection Route of

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026