An interventional study of Erector Spinae Plane Block and Serratus Anterior Plane Block in Aortic Coarctation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Months to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 28 is below the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
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
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%)
Total intraoperative fentanyl consumption by mcg/kg.
calculating the total dose of fentanyl used intraoperatively
Time frame: Intra-operatively up to extubation
Time (in minutes) to 1st rescue analgesia (morphine)
estimating the time of the need for 1st dose of morphine which was given for pain scores ≥ 4
Time frame: 1st 24 hours postoperatively
Heart rate and systolic blood pressure
recorded at 5 minutes after intubation (baseline value), before skin incision at 15 minutes after the block, after skin incision, after rib retraction, after aortic clamping, after aortic declamping, immediately after skin closure, and at 15 minutes after extubation
Time frame: up to 15 minutes after extubation
The need and the dose of sodium nitroprusside after aortic clamping
sodium nitroprusside was given to control the hypertensive response to aortic clamping
Time frame: from aortic clamping until removal of the clamps
total morphine dose
morphine was given for pain scores ≥ 4
Time frame: up to 24 hours after surgery
Face, Legs, Activity, Cry, Consolability (FLACC) score
Postoperative pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score every 2 hours for the first 24 hours postoperatively. If the FLACC score ≥ 4, 0.02 mg/kg morphine IV was administered as rescue analgesia to be repeated every 15-20 minutes till the pain score reaches \< 4, not exceeding 0.2 mg/kg every 6 hours
Time frame: up to 24 hours after surgery
Plan to share: No
Ran from Aug 2024 to primary completion in Apr 2025, 7 months.
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