Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics

NCT ID: NCT03701126

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-04-01

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type: PROCEDURE

ultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).

Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

Dose 1ml /kg of patient body weight

Ultra-sound guidance

Intervention Type: DEVICE

using superficial high frequency probe to guide regional anesthesia

group B

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

Group Type: ACTIVE_COMPARATOR

Caudal Block

Intervention Type: PROCEDURE

ultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).

Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

Dose 1ml /kg of patient body weight

Ultra-sound guidance

Intervention Type: DEVICE

using superficial high frequency probe to guide regional anesthesia

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Bupivacaine 0.25% Injectable Solution

Dose 1ml /kg of patient body weight

Intervention Type: DRUG

Ultra-sound guidance

using superficial high frequency probe to guide regional anesthesia

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohammed Abdullah Seliem Mekawy

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Refky, MD

Role: STUDY_CHAIR

Faculty of medicine, zagazig university, Egypt

Doaa M Farid, MD

Role: STUDY_CHAIR

Faculty of medicine, zagazig university, Egypt

Ayat A Amer, MD

Role: STUDY_DIRECTOR

Faculty of medicine, zagazig university, Egypt

Locations

Faculty of medicine, Zagazig University.

Zagazig, Alsharkia, Egypt

Countries

Egypt

Central Contacts

Mohammed AS Mekawy, MSc

Role: CONTACT

mmekawy40@yahoo.com

+201154183388

Facility Contacts

Mohammed AS Mekawy, MSc

Role: primary

Other Identifiers

TAP/caudal block in pediatric

Identifier Type: -

Identifier Source: org_study_id