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Clinical Trials/NCT03701126
NCT03701126
Unknown
Not Applicable

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

Zagazig University1 site in 1 country44 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Ultra-sound guidance
Conditions
Anesthesia
Sponsor
Zagazig University
Enrollment
44
Locations
1
Primary Endpoint
Time for first analgesic request
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
April 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Abdullah Seliem Mekawy

Principal investigator

Zagazig University

Eligibility Criteria

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.

Arms & Interventions

group B

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Ultra-sound guidance

group A

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Transversus Abdominis Plane Block

group A

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Bupivacaine 0.25% Injectable Solution

group A

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Ultra-sound guidance

group B

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Caudal Block

group B

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

Intervention: Bupivacaine 0.25% Injectable Solution

Outcomes

Primary Outcomes

Time for first analgesic request

Time Frame: 24 hours after surgery

by investigator till hospital discharge, then through telephone with parents after discharge

Secondary Outcomes

  • Total Opioid consumpsion(During operation)
  • Total Ibuprofen consumption(24 hours after surgery)
  • post operative pain score.(2 , 4 , 8 , 12 & 24 hours after surgery.)
  • parents satisfaction score.(24 hours after surgery)

Study Sites (1)

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