Postoperative pain management after heart valve surgery using incisional injection of local anaesthetic and patient controlled analgesia

• Conditions: Mitral or aortic valve disease; MedDRA version: 17.1Level: LLTClassification code 10049495Term: Heart valve operation NOSSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-004295-28-FI
• Lead Sponsor: Oulu University Hospital, Department of Anaesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Patients with mitral- or aortic valve disease requiring elective isolated valve surgery.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

- allergy to any gdrug used in the study
- inability to use PCA-device
- severe heart failure ( preoperative EF<35% or Cardiac Index < 2,0 l/m2 after operation in spite of inotropic medication)
- severe liver disease
- kidney failure ( S-krea > 110)
- age under 18 years and over 75 years
- significant obesity ( BMI>35)
- emergency surgery
- sleep apnea
- delayed awakening from anesthesia ( > 12 hours)
- postoperative bleeding requiring hemostasis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified