Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries

Study Overview
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Brief Summary
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Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each): Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg. Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).

Official Title
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Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: caudal block
* Drug: Dexmedetomidine
* Procedure: TAP
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-9 years old Physical status I and II class of the American Society of Anesthesiologists (ASA) Unilateral elective surgeries below the umbilicus Exclusion Criteria: Parents or legal guardian refusal. History of developmental delay or mental retardation Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block. Hemodynamic unstable patient.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal block with bupivacaine and dexmedetomidine<br>Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg. | Procedure: caudal block<br>* bupivacaine 0.25% in a dose of (1 ml / kg)<br>* Other names: bupivacaine;Drug: Dexmedetomidine<br>* dexmedetomidine 1μg/ kg.<br>Drug: Bupivacain<br>* bupivacaine 0.25% in a dose of (0.5 ml / kg<br>|
| Active Comparator: TAP block with bupivacaine<br>TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg). | Procedure: TAP<br>* analgesia<br>Drug: Bupivacain<br>* bupivacaine 0.25% in a dose of (0.5 ml / kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st analgesic requirement | Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h) | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate (HR) | Hemodynamic assessment | 12 hours | 
| systolic Blood Pressure (BP) | Hemodynamic assessment | 12 hours | 
| diastolic Blood Pressure (BP) | Hemodynamic assessment | 12 hours | 
| SpO2 -Hemodynamic assessment |  | 12 hours | 
| Total paracetamol consumption |  | 12 hours | 
| post operative pain score | post operative pain score upon arrival to recovery room and then 2, 4,6, 8 , and 12 hours after surgery using Faces pain scale-revised. | 12 hours |