Clinical trial

The Efficacy of Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery

Name

Medipol Hospital 36

Description

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.

Trial arms

Trial start

2024-02-25

Estimated PCD

2024-10-20

Trial end

2024-11-10

Status

Recruiting

Treatment

RIFPB block

For RIFPB, a local anesthetic will be injected into the plane between the costal cartilage and the rectus abdominis muscle at the 6th-7th costal cartilage under US guidance. The in-plane technique will be used. After confirming the block location, 10 ml of 0.25% concentration marcaine (bupivacaine) will be used (bilateral).

Arms:

Group PR = RIFPB and PIFB group

Postoperative analgesia management

Patients will be administered 10mg/kg paracetamol in the postoperative period every eight hours. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administered as a rescue analgesic.

Arms:

Group Control, Group PR = RIFPB and PIFB group

PIFPB block

For PIFPB; the ultrasound probe for PIFB is placed 2-3 cm lateral to the upper third of the sternum, parallel to the sternum. A local anesthetic of 15 ml of 0.25% concentration of marcaine (bupivacaine) will be used between the pectoralis major and external intercostal muscles (bilateral).

Arms:

Group PR = RIFPB and PIFB group

Size

Primary endpoint

Global recovery scoring system / Quality of Recovery 15 questionairre

Change from baseline score at postoperative 24 hour

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Outcomes Assessor and participant were blinded to the study', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-02-29

1 organization

2 products

1 indication

Organization

Product

Indication

Product