NCT06567275

Brief Summary

Pain is considered to be subjective, however, in children, it is believed to be felt rather than expressed because they often depend on the caregiver for their safety and well-being. There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neurohormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for pediatric patients is mandatory. The use of highly potent opioids for pediatric cardiothoracic anesthesia has gained widespread popularity during the last 20 years. In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery. serratus anterior plane block guided by ultrasound was developed by Blanco et al, it is a novel technique in the management of pain following thoracic procedures. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. The Erector Spinae Plane Block (ESPB) is also one of the recently known pain-controlling techniques used in pediatric cardiothoracic surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. Chin et al. documented the cadaveric spread of local anesthetic and noted that, radiologically, the local anesthetic spread extended 3 or 4 levels cranially and caudally from the site of injection. These two blocks have been compared in a study by wang HJ et al in patients undergoing radical mastectomy. To our knowledge, the comparison of serratus Plane Block versus erector spinae plane block in aortic coarctectomy operations in pediatric patients has not been investigated yet. This has encouraged the performance of the present study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 24, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

July 2, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 20, 2024

Last Update Submit

June 30, 2025

Conditions

Keywords

erector spinae plane blockserratus anterior plane blockaortic coarctectomy

Outcome Measures

Primary Outcomes (1)

  • Total intraoperative fentanyl consumption by mcg/kg.

    calculating the total dose of fentanyl used intraoperatively

    Intra-operatively up to extubation

Secondary Outcomes (5)

  • Time (in minutes) to 1st rescue analgesia (morphine)

    1st 24 hours postoperatively

  • Heart rate and systolic blood pressure

    up to 15 minutes after extubation

  • The need and the dose of sodium nitroprusside after aortic clamping

    from aortic clamping until removal of the clamps

  • total morphine dose

    up to 24 hours after surgery

  • Face, Legs, Activity, Cry, Consolability (FLACC) score

    up to 24 hours after surgery

Study Arms (2)

erector spinae plane block

EXPERIMENTAL

Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).

Procedure: Erector Spinae Plane Block

serratus anterior plane block

EXPERIMENTAL

Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).

Procedure: Serratus Anterior Plane Block

Interventions

Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%)

erector spinae plane block

Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%)

serratus anterior plane block

Eligibility Criteria

Age3 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: 3 months-2 years.
  • RACHS-1 score 3.
  • Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.

You may not qualify if:

  • Patients whose parents or legal guardians refuse to participate.
  • Preoperative mechanical ventilation.
  • Preoperative inotropic drug infusion.
  • Perioperative cardiopulmonary arrested patients.
  • Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
  • History of mental retardation or delayed development that may interfere with pain intensity assessment.
  • Known or suspected coagulopathy. (PT \< 75% of control)
  • Any congenital anomalies or any infection at the site of injection.
  • Known or suspected allergy to any of the studied drugs.
  • liver enzymes elevated more than the normal values.
  • Renal function impairment (Creatinine value more than 1.2mg/dl or BUN more than 20mg/dl).
  • Heart failure patients
  • Redo patients and previous catheter dilatations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abu Elreish Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Gado AAM, Atia MAM, Roman AA, Elsadeq WM, Jaccoub VF. Analgesic efficacy of ultrasound guided erector spinae plane block versus serratus anterior plane block in pediatric patients undergoing aortic coarctectomy; a randomized controlled study. BMC Anesthesiol. 2025 Jul 30;25(1):370. doi: 10.1186/s12871-025-03256-y.

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wafaa M Elsadeq

    Professor of Anesthesia, Pain Management, and Surgical ICU Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start

August 24, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

July 2, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations