Ultrasound-Guided Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Surgery

NCT05526469 | Completed DMC

• 1 other identifier: FMASU R 110/ 2022
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Objectives: Opioid based analgesia is the main used technique in pediatric cardiac surgery which preclude fast-track recovery. Ultrasound guided regional fascial plane blocks are used recently in many pediatric surgical procedure with excellent outcomes and very low rate of complication. The investigators will compare ultrasound guided serratus anterior plane block and erector spinae plane block in pediatric cardiac surgical procedure through thoracotomy approach regarding effectiveness of postoperative analgesia, incidence of complications and effect in ultrafast track recovery. Methods: The investigators will enroll 64 pediatric patients aged from 6 months to 10 years undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass in this prospective randomized study. After induction of general anesthesia, the patients will be randomly assigned into 2 groups based regional fascial plane block given (SAP group will receive ultrasound guided single shot serratus anterior plane block and ESP group will receive ultrasound guided single shot erector spinae plane block). The effectiveness of postoperative analgesia using FLACC pain score will be recorded as the primary outcome while total consumption of analgesics, the time for rescue analgesia, incidence of complications, and incidence of need for re-intubation will be recorded as the secondary outcomes.

Conditions

Congenital Heart Disease

Keywords

Pediatric; Cardiac surgery; Ultrasound; Serratus anterior plane block; Erector spinae plan block

Outcome Measures

Primary Outcomes (1)

• Effectiveness of postoperative analgesia

  We will test the effect of serratus anterior plane block in adequacy of postoperative analgesia (using FLACC pain scale "from 0 to 10") compared to erector spinae plane block

  6 months

Secondary Outcomes (3)

• Incidence of complications

  6 months

• Tracheal re-intubation

  6 months

• Length of ICU stay

  6 months

Study Arms (2)

Group serratus anterior plane (SAP)

ACTIVE COMPARATOR

patients will receive ultrasound guided single shot serratus anterior plane block with 0.5 ml/kg bupivacaine 0.25%

Procedure: Serratus anterior plane block; Drug: Bupivacaine 0.25% Injectable Solution

Group erector spinae plane (ESP)

ACTIVE COMPARATOR

patients will receive ultrasound guided single shot erector spinae plane block with 0.5 ml/kg bupivacaine 0.25%

Procedure: erector spinae plane blocks; Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Serratus anterior plane block PROCEDURE

patients in this group will receive ultrasound guided single shot serratus anterior plane block for pain control intra and postoperative

Group serratus anterior plane (SAP)

erector spinae plane blocks PROCEDURE

patients in this group will receive ultrasound guided single shot erector spinae plane block for pain control intra and postoperative

Group erector spinae plane (ESP)

Bupivacaine 0.25% Injectable Solution DRUG

Patients in both group will receive 0.5 ml/kg bupivacaine 0.25% injected locally in the muscle plane

Group erector spinae plane (ESP); Group serratus anterior plane (SAP)

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status II-III.
• Age between 6 months and 10 years old,
• of both sexes,
• undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass e.g. ASD closure, PDA ligation, and aortic coarctation repair.

You may not qualify if:

• Patients weight less than 5 kg,
• Patients with coagulopathy,
• previous cardiac surgery,
• emergency procedure,
• previous thoracotomy or sternotomy,
• surgery through sternotomy incision,
• patients with complex surgical repair,
• patients need postoperative mechanical ventilation.
• hypersensitivity to local anesthetics,
• infection at site of block injection,
• parent or guardian refusal.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management

Cairo, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: September 2, 2022
• Study Start: July 24, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. For more information or to submit a request, please contact akram.amer@med.asu.edu.eg

Locations

EG (1)