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Pediatric Pectointercostal and ESP Block

Ç

Çukurova University

Status and phase

Enrolling
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Pectointercostal and ESP block

Study type

Interventional

Funder types

Other

Identifiers

NCT05590026
Pediatric Pectointercostal

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Pectointercostal and ESP block
Active Comparator group
Description:
Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.
Treatment:
Drug: Pectointercostal and ESP block
No Block
Placebo Comparator group
Description:
No block will apply to the patient
Treatment:
Drug: Pectointercostal and ESP block

Trial contacts and locations

1

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Central trial contact

Ebru Biricik; Ebru Biricik

Data sourced from clinicaltrials.gov

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