Pediatric Pectointercostal and ESP Block

Postoperative Pain Clinical Trial

Official title:

Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590026
• Other study ID #: Pediatric Pectointercostal
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2022
• Source: Cukurova University
• Contact: Ebru Biricik
• Phone: +905052420223
• Email: ebrubiricik01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesia	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	24 hours in Postanesthesia care unit (PACU)
Primary	Postoperative morphine consumption	Postoperative morphine consumption will record till the postoperative 24 th hours	24 hours in Postanesthesia care unit (PACU)
Secondary	Postoperative agitation	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.	First 24 hours at Postanesthesia care unit (PACU)