Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03701126
• Other study ID #: TAP/caudal block in pediatric
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2018
• Source: Zagazig University
• Contact: Mohammed AS Mekawy, MSc
• Phone: +201154183388
• Email: mmekawy40[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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).
• Caudal Block
ultrasound (US) guided caudal 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

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig University.	Zagazig	Alsharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for first analgesic request	by investigator till hospital discharge, then through telephone with parents after discharge	24 hours after surgery
Secondary	Total Opioid consumpsion	Total amount of intra-operative fentanyl consumption.	During operation
Secondary	Total Ibuprofen consumption	Total amount of oral ibuprofen consumption postoperative.	24 hours after surgery
Secondary	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.
Secondary	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