Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Transversus Abdominis Plane Block; Drug: Bupivacaine 0.25% Injectable Solution; Device: Ultra-sound guidance; Procedure: Caudal Block

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alsharkia
    • Zagazig, Alsharkia, Egypt, 44519
      • Faculty of medicine, Zagazig University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Chair: Mohammed A Refky, MD, Faculty of medicine, zagazig university, Egypt; Study Chair: Doaa M Farid, MD, Faculty of medicine, zagazig university, Egypt; Study Director: Ayat A Amer, MD, Faculty of medicine, zagazig university, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: TAP/caudal block in pediatric

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No