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Completed

NCT Number: NCT06567275

Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy

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.

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Key information

Age range

3 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abu Elreish Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Erector Spinae Plane Block

Procedure

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%)

Serratus Anterior Plane Block

Procedure

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%)

Primary outcomes

  1. Total intraoperative fentanyl consumption by mcg/kg.

    Time frame: Intra-operatively up to extubation

    calculating the total dose of fentanyl used intraoperatively

Secondary outcomes

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

    Time frame: 1st 24 hours postoperatively

    estimating the time of the need for 1st dose of morphine which was given for pain scores ≥ 4

  2. Heart rate and systolic blood pressure

    Time frame: up to 15 minutes after extubation

    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

  3. The need and the dose of sodium nitroprusside after aortic clamping

    Time frame: from aortic clamping until removal of the clamps

    sodium nitroprusside was given to control the hypertensive response to aortic clamping

  4. total morphine dose

    Time frame: up to 24 hours after surgery

    morphine was given for pain scores ≥ 4

  5. Face, Legs, Activity, Cry, Consolability (FLACC) score

    Time frame: up to 24 hours after surgery

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block in Pediatric Patients Undergoing Aortic Coarctectomy , a Randomized Controlled Study .

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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