Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics

Study Overview
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Brief Summary
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The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.

Detailed Description
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The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. However, in recent days there is a trend toward the use of peripheral nerve blockade wherever applicable, given the lower incidences of adverse effects when compared with neuron-axial techniques. Furthermore, there may be specific anatomic variations or abnormalities which preclude the use of caudal block. The abdominal wall consists of three muscular layers, the external oblique abdominis muscle (EOAM), the internal oblique abdominis muscle (IOAM), and the tranversus abdominis muscle (TAM), and their associated fascial sheaths. The central abdominal wall also includes the rectus abdominis muscles and its associated fascial sheath. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuron-fascial plane. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.

Official Title
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Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block in Inguinal Hernia Repair Surgery in Pediatrics

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Transversus Abdominis Plane Block
* Procedure: Caudal Block
* Drug: Bupivacaine 0.25% Injectable Solution
* Device: Ultra-sound guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American society of anesthiologists) physical status grade I-II. Operations not extending more than two hours. Unilateral surgeries. Exclusion Criteria: Refusal of parents. Urgent cases. Bilateral or Complicated hernias (i.e., obstructed, strangulated, irreducible …). Other contraindication of regional anesthesia e.g. septic focus at site of injection, patients on anticoagulant therapy or suffering from coagulopathy, allergy to local anesthetic drug. Prolonged operations more than two hours.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance | Procedure: Transversus Abdominis Plane Block<br>* ultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).<br>Drug: Bupivacaine 0.25% Injectable Solution<br>* Dose 1ml /kg of patient body weight<br>Device: Ultra-sound guidance<br>* using superficial high frequency probe to guide regional anesthesia<br>|
| Active Comparator: group B<br>Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance | Procedure: Caudal Block<br>* ultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).<br>Drug: Bupivacaine 0.25% Injectable Solution<br>* Dose 1ml /kg of patient body weight<br>Device: Ultra-sound guidance<br>* using superficial high frequency probe to guide regional anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for first analgesic request | by investigator till hospital discharge, then through telephone with parents after discharge | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid consumpsion | Total amount of intra-operative fentanyl consumption. | During operation | 
| Total Ibuprofen consumption | Total amount of oral ibuprofen consumption postoperative. | 24 hours after surgery | 
| post operative pain score. | Pain assessment by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) by investigator till hospital discharge, then through telephone with parents after discharge | 2 , 4 , 8 , 12 & 24 hours after surgery. | 
| parents satisfaction score. | satisfaction were measured on a 5 point scale of extremely dissatisfied to extremely satisfied as follows: 1- Completely dissatisfied (worst), 2- Dissatisfied 3- Not satisfied, nor dissatisfied, 4- Satisfied, 5- Completely satisfied (best). | 24 hours after surgery |