The effect local anaesthesia of transversus thoracis muscle plane block on postoperative pain and oxycodone consumption after cardiac surgery

Phase 1

• Conditions: cardiac disease necessitating surgery with sternotomy; MedDRA version: 20.0Level: LLTClassification code 10046972Term: Valvular heart disease NOSSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004178-23-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.18 - 80 years of age
2.Scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
3.Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
4.Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
5.Written informed consent

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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.A previous history of intolerance to the study drug or related compounds and additives
2.Redo surgery
3.Combined CABG and heart valve surgery
4.Endocarditis and/or mediastinitis
5.Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
6.Patients younger than 20 years or older than 80 years.
7.Body weight < 60 kg
8.BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
9.Existing significant liver or kidney disease
10.History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
11.Cardiac insufficiency, ejection fraction (LVEF) < 30 %
12.Patients with a diagnosis for neuropathic pain or chronic pain syndrome
13.Insulin dependent diabetes mellitus with neuropathy
14.Participating in other clinical trial under TTP study
15.Donation of blood for 4 weeks prior and during the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of transversus thoracis muscle plane block (TTP) on pain ratings, using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with sternotomy. ;Secondary Objective: To investigate the effect of transversus thoracis muscle plane block (TTP) on reduction in oxycodone consumption, on sensations that are considered to be caused by systemic toxicity of ropivacaine, and on the length of ICU and hospital stay<br>;Primary end point(s): Pain scores (NRS) at rest and on movement ;Timepoint(s) of evaluation of this end point: 24, 48, 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Reduction in oxycodone consumption<br>-Any sensation that is considered to be caused by systemic toxicity of ropivacaine<br>-Length of ICU and hospital stay<br>;Timepoint(s) of evaluation of this end point: 24, 48 and 72 hours postoperatively