Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy
Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block in Pediatric Patients Undergoing Aortic Coarctectomy , a Randomized Controlled Study .
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interventional
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1 country
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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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
August 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedJuly 2, 2025
August 1, 2024
8 months
August 20, 2024
June 30, 2025
Conditions
Keywords
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
EXPERIMENTALUltrasound-guided erector spinae 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
EXPERIMENTALUltrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).
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%)
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%)
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Abu Elreish Hospital
Cairo, Egypt
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.
PMID: 40739624DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wafaa M Elsadeq
Professor of Anesthesia, Pain Management, and Surgical ICU Faculty
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