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

Postoperative pain management after heart valve surgery using parasternal block and PCA Oxycodone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004295-28-FI

Enrollment

Registered

2014-10-30

Start date

2014-11-14

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

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

Interventions

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 Concentra

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - allergy to any gdrug used in the study - inability to use PCA-device - severe heart failure ( preoperative EF 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

Design outcomes

Primary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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

Measure	Time frame
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.;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	—

Countries

Finland

Contacts

Public ContactOYS Anestesiaklinikka

Oulu University Hospital, Department of Anaesthesia

vesa.pakanen@ppshp.fi

Outcome results

None listed

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