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

• Register: EUCTR
• Last refreshed on: 17 November 2014
• Main ID: EUCTR2014-004295-28-FI
• Date of registration: 30/10/2014
• Prospective Registration: Yes
• Primary sponsor: Oulu University Hospital, Department of Anaesthesia
• Public title: Postoperative pain management after heart valve surgery using incisional injection of local anaesthetic and patient controlled analgesia
• Scientific title: Postoperative pain management after heart valve surgery using parasternal block and PCA Oxycodone
• Date of first enrolment: 14/11/2014
• Target sample size: 64
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004295-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: OYS Anestesiaklinikka
• Affiliation: Oulu University Hospital, Department of Anaesthesia

• Name: OYS Anestesiaklinikka
• Affiliation: Oulu University Hospital, Department of Anaesthesia

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mitral or aortic valve disease
MedDRA version: 17.1 Level: LLT Classification code 10049495 Term: Heart valve operation NOS System Organ Class: 100000004865

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Intervention(s)

Trade Name: Chirocaine 2,5 mg/ml
Pharmaceutical Form: Injection
CAS Number: 27262-48-2
Other descriptive name: LEVOBUPIVACAINE HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2,5-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Infiltration

Primary Outcome(s)

Main Objective: Patient undergoing elective mitral- or aortic valve surgery, performed under standard surgery and anesthesia, will be randomized to undergo either incisional infiltration of local anesthetic, parasternal block ( active treatment group) or infiltration of saline as placebo before wound closure. The purpose of the study is to test the hypothesis that parasternal block improves postoperative analgesia in cardiac surgical patients and their requirement of oxycodone is decreased.

Primary end point(s): The use of oxycodone is at least 25% lesser in active treatment group than placebo group.

Timepoint(s) of evaluation of this end point: 48 hours after operation.

Secondary Objective: Secondary objective is to test hypothesis that patients with incisional infiltration of local anesthetic have shorter awakenig time and hospitalization time. Also the hypothesis is that patient in active treatment group has less chronic postsurgical pain.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. 1, 2, 3, 4, 8, 24, 48, 72 hours after operation
2. When patients hospitalization ends
3. 1 month and 6 months after operation

Secondary end point(s): 1. The active treatment group has less pain after operation.
2. The active treatment group has shorter hospitalization time.
3. The active treatment group has less chronic postsurgical pain.

Secondary ID(s)

STER-AMVR-01

Source(s) of Monetary Support

Oulu University Hospital