Clinical trial

Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery

Name

Pediatric Pectointercostal

Description

American Society of Anaesthesiologist physical status II-III, aged between 2, 12 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks. 2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores

Trial arms

Trial start

2022-10-15

Estimated PCD

2023-08-15

Trial end

2023-08-15

Status

Recruiting

Phase

Early phase I

Treatment

Pectointercostal and ESP block

Both Pectointercostal at between 4th and 5th costa and ESP block will apply at thoracal 6 level to the patient.

Arms:

No Block, Pectointercostal and ESP block

Other names:

Fascia plane blocks

Size

Primary endpoint

Postoperative analgesia

24 hours in Postanesthesia care unit (PACU)

Postoperative morphine consumption

24 hours in Postanesthesia care unit (PACU)

Eligibility criteria

Inclusion Criteria: * Ages between 2-12 years * ASA II-III children * The children who undergoing open heart surgery Exclusion Criteria: * Coagulopaty * Allergy of local anesthetic * Liver and renal failure * Obesity (BMI \>35kg/m2) * Infection at the block area

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-04-27

1 organization

1 product

1 indication

Organization

Cukurova University

Product

Pectointercostal and ESP block

Indication

Postoperative Pain