Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics

Not Applicable

• Conditions: Anesthesia
• Interventions: Procedure: Caudal Block; Procedure: Transversus Abdominis Plane Block; Drug: Bupivacaine 0.25% Injectable Solution; Device: Ultra-sound guidance

• Registration Number: NCT03701126
• Lead Sponsor: Zagazig University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-06
• Last Update Submitted: 2018-10-06
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09
• Study Start: 2018-11-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Bupivacaine 0.25% Injectable Solution	Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance
group B	Caudal Block	Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance
group A	Transversus Abdominis Plane Block	Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance
group A	Ultra-sound guidance	Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance
group B	Bupivacaine 0.25% Injectable Solution	Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance
group B	Ultra-sound guidance	Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Primary Outcome Measures

Name	Time	Method
Time for first analgesic request	24 hours after surgery	by investigator till hospital discharge, then through telephone with parents after discharge

Secondary Outcome Measures

Name	Time	Method
Total Opioid consumpsion	During operation	Total amount of intra-operative fentanyl consumption.
Total Ibuprofen consumption	24 hours after surgery	Total amount of oral ibuprofen consumption postoperative.
post operative pain score.	2 , 4 , 8 , 12 & 24 hours after surgery.	Pain assessment by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) by investigator till hospital discharge, then through telephone with parents after discharge
parents satisfaction score.	24 hours after surgery	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).

Trial Locations

Locations (1)

Faculty of medicine, Zagazig University.; 🇪🇬 Zagazig, Alsharkia, Egypt