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Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery

M

Medipol University

Status

Enrolling

Conditions

Cardiac Disease

Treatments

Drug: PIFPB block
Other: Postoperative analgesia management
Drug: RIFPB block

Study type

Interventional

Funder types

Other

Identifiers

NCT06285773
Medipol Hospital 36

Details and patient eligibility

About

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.

Full 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 heart's 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-III
  • Scheduled for cardiac surgery with elective median sternotomy under general anesthesia

Exclusion criteria

  • a personal or family history of malignant hyperthermia,
  • opioid sensitivity,
  • alcohol or drug addiction,
  • liver or kidney disease,
  • skin infection in the area to be blocked,
  • thoracic deformity,
  • patients who are allergic to their medications,
  • patients who do not agree to participate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group PR = RIFPB and PIFB group
Active Comparator group
Description:
Recto-intercostal fascial plane block (RIFPB) and Pecto-intercostal fascial plane block (PIFB) will be applied
Treatment:
Other: Postoperative analgesia management
Drug: RIFPB block
Drug: PIFPB block
Group Control
Other group
Description:
No block will be applied.
Treatment:
Other: Postoperative analgesia management

Trial contacts and locations

1

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Central trial contact

Burak Omur, Assist Prof, MD; Bahadir Ciftci, Assoc Prof, MD

Data sourced from clinicaltrials.gov

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