Regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) placement

Not Applicable

• Conditions: Postoperative Pain; Cardiovascular Procedure; Regional anaesthesia; Pacemaker insertion; Anaesthesiology - Pain management; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621001386820
• Lead Sponsor: Wroclaw Medical University, Poland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-14
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Age > 18 years old and < 90 years old
2.Classification of the American Society of Anesthesiologists (ASA) III/IV
3.The obtained informed and written consent to participate in the study

Exclusion Criteria

1.Non-acceptance for regional anesthesia
2.Allergy to local anesthetic drugs
3.Serious coagulopathy PLT <50x10^3, INR>2,5 APTT>40sec
4.Infection in puncture area

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of pain assessed by the patient by means of the Numerical Rating Scale (NRS)<br>[Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours];The severity of pain assessed by the patient by means of the Visual Analogue Scale (VAS)[Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours];The quality of postoperative recovery assessed by the patient by means of the Quality-of-Recovery 15 (QoR-15)[Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours]

Secondary Outcome Measures

Name	Time	Method
Composite secondary outcome: the level of selected vital signs in the clinical monitoring of hemodynamic stability and effectiveness of anesthesia: heart rate measured using electrocardiography, blood pressure measured using a sphygmomanometer, oxygen saturation measured using a pulse oximeter.<br>[Baseline, intraoperative every 15 minutes of the procedure, and postoperative15 minutes, 30 minutes, 45 minutes, and 60 minutes..];Requirement for use of coanalgesics by accessing patient medical record<br>[Baseline, postoperative 6 hours, 12 hours,18 hours, 24 hours, 36 hours, and 48 hours];The quality of the operator according to conditions during the combined block method using PECS I, PECS II, and SPB assessed by means of the Operator's Condition Assessment Score which was designed specifically for this study[Intreoperatively]