Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Procedure: 1. no block; Procedure: 3. deep parasternal block; Procedure: 2. superficial parasternal block

Study type: Interventional

Funder types: Other

Identifiers

NCT06387095

2024/01/756

Details and patient eligibility

About

Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.

Full description

The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Performing median sternotomy
• Elective case
• Over 18 years of age; under 80 years of age
• ASA II-III patients

Exclusion criteria

• Emergency cases
• Patients undergoing minimally invasive surgery
• Patients with a history of opioid use in the last 30 days
• Redo cases
• Patients with left ventricular ejection fraction less than 30%
• Patients with severe hepatic or renal insufficiency
• Patients with chronic pain before surgery (migraine, fibromyalgia)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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300 participants in 3 patient groups

1. control group

Active Comparator group

Description:

control group. block will not be applied to this group and the patient's analgesia needs will be provided with patient-controlled analgesia devices.

Treatment:

Procedure: 1. no block

2. superficial parasternal plane block group

Active Comparator group

Description:

superficial parasternal plane block group. superficial paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.

Treatment:

Procedure: 2. superficial parasternal block

3. deep parasternal plane block group

Active Comparator group

Description:

deep parasternal plane block group. deep paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.

Treatment:

Procedure: 3. deep parasternal block