Pediatric Pectointercostal and ESP Block

NCT ID: NCT05590026

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-08-15

Brief Summary

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

Detailed Description

American Society of Anaesthesiologist physical status II-III, aged between 2-12, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks.2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores. FLACC, Watcha scores, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the FLACC score is higher than 4, morphine 0.015 mg/kg will administer intravenously.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pectointercostal and ESP block

Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.

Group Type: ACTIVE_COMPARATOR

Pectointercostal and ESP block

Intervention Type: DRUG

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

No Block

No block will apply to the patient

Group Type: PLACEBO_COMPARATOR

Pectointercostal and ESP block

Intervention Type: DRUG

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

Interventions

Pectointercostal and ESP block

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

Intervention Type: DRUG

Other Intervention Names

Fascia plane blocks

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

ebru biricik

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Biricik

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Cukurova University

Adana, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ebru Biricik

Role: CONTACT

ebrubiricik01@gmail.com

+905052420223

Ebru Biricik

Role: CONTACT

ebrubiricik01@gmail.com

+903223386084

Facility Contacts

Ebru Biricik, MD

Role: primary

ebrubiricik01@gmail.com

05052420223

Other Identifiers

Pediatric Pectointercostal

Identifier Type: -

Identifier Source: org_study_id