Viewing Study NCT06285773



Ignite Creation Date: 2024-05-06 @ 8:11 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06285773
Status: RECRUITING
Last Update Posted: 2024-02-29
First Post: 2024-02-19

Brief Title: Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery
Sponsor: Medipol University
Organization: Medipol University

Study Overview

Official Title: The Efficacy of Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In cardiac surgeries performed with median sternotomy mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks and sometimes the sternotomy incision extends below the T6 dermatome Recto intercostal fascial plane block RIFPB has been defined as a complementary block for analgesia of this region This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery coronary artery bypass with median sternotomy
Detailed Description: Open heart surgery is defined as surgery performed on the heart valves arteries and other heart structures by cutting the sternum with a median sternotomy Cardiovascular diseases are prevalent in the general global population and affect most of the older adult population With the increase in life expectancy in recent years there has been a significant increase in surgical procedures for cardiovascular diseases ERAS recommends effective perioperative pain control to improve outcomes after Cardiac Surgery Inadequate pain control after open heart surgery causes decreased mobilization increased respiratory complications prolonged hospital stays and chronic pain

Post-heart surgery pain is most intense during the first two days and then decreases Considering that 17 of patients report chronic pain after cardiac surgery it is crucial to provide effective analgesia in the early postoperative period

Failure to adequately relieve post-operative pain may lead to increased pulmonary complications as a result of inability to breathe deeply coughing due to fear of pain and consequent inability to clear bronchial secretions Moreover increased endogenous catecholamines due to surgery and pain increase the hearts oxygen consumption by causing tachycardia and hypertension This situation causes ischemia heart failure and arrhythmias in patients who have undergone cardiac surgery

In general postoperative pain is reduced with opioids which can cause various complications Although the use of opioids is recommended in cardiac surgery due to their ischemic effects multimodal perioperative pain management strategies are recommended in current anesthesia The use of regional anesthesia as part of multimodal strategies is steadily increasing in cardiac surgeries performed through median sternotomy Despite multimodal analgesia strategies using regional techniques post-operative pain still emerges as an important problem in open heart surgery with median sternotomy

The leading causes of pain after cardiac surgery are sternotomy incisions chest retraction dissection of the internal mammary artery thoracic tubes sternal wires and visceral pain Sternal pain is transmitted through intercostal nerves originating from T2-T6 spinal nerve roots whereas various regional techniques are used for analgesia in parasternal region surgeries Amongst these techniques while parasternal blocks can be preferred as fascial plane blocks these aim to block the anterior cutaneous branches of the T2-T6 thoracic nerves Pectointercostal fascial block PIFB is an effective technique for controlling sternal pain in heart surgeries where median sternotomy is performed

In cardiac surgeries performed with median sternotomy mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks and sometimes the sternotomy incision extends below the T6 dermatome Recto intercostal fascial plane block RIFPB has been defined as a complementary block for analgesia of this region This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery coronary artery bypass with median sternotomy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None