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Pediatric Pectointercostal and ESP Block

Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05590026
Enrollment
60
Registered
2022-10-21
Start date
2022-10-15
Completion date
2023-08-15
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

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

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative analgesia24 hours in Postanesthesia care unit (PACU)Postoperative analgesia will asses Face, Legs, Activity, Cry, Consolability (FLACC) score in (Postanesthesia care unit) PACU till the 24th hours postoperatively. FLACC score reflects pain score between 0-10. 0 means zero pain, 10 means worse pain score
Postoperative morphine consumption24 hours in Postanesthesia care unit (PACU)Postoperative morphine consumption will record till the postoperative 24 th hours

Secondary

MeasureTime frameDescription
Postoperative agitationFirst 24 hours at Postanesthesia care unit (PACU)The patients will asses with Watcha score for postoperative agitation in Postanesthesia care unit (PACU) till the postoperative 24th hours. Watcha score reflects delirium score (scale between 0 to 4). A child with a score of \>2 on the Watcha score can be considered to have emergence delirium. (Points between 0-4) Watcah is one of the author's name.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEbru Biricik
ebrubiricik01@gmail.com+905052420223
Backup ContactEbru Biricik
ebrubiricik01@gmail.com+903223386084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026