Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

Study Overview
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Brief Summary
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Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.

Official Title
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Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study

Conditions
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Paediatric, Surgery, Analgesia, Anesthesia

Intervention / Treatment
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* Procedure: Erector Spinae Plain Block
* Procedure: Intra-Venous Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I - II. Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy. Exclusion Criteria: Patient's next of kin refusal. Allergy to local anaesthetics. Infection at the site of injection. Coagulopathy.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB group<br>Erector Spinae Plain Block | Procedure: Erector Spinae Plain Block<br>* Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.<br>Procedure: Intra-Venous Analgesia<br>* Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.<br>|
| Active Comparator: IV Analgesia group<br>Intra-Venous Analgesia | Procedure: Intra-Venous Analgesia<br>* Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tramadol consumption. | Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae plain block, Ultrasound-guided, Paediatric, Upper abdominal surgery, Analgesia, Anesthesia