Clinical trial NCT03701126: Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block in Inguinal Hernia Repair Surgery in Pediatrics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-10-09
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time for first analgesic request
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Total Opioid consumpsion
timeFrame: During operation
measure: Total Ibuprofen consumption
timeFrame: 24 hours after surgery
measure: post operative pain score.
timeFrame: 2 , 4 , 8 , 12 & 24 hours after surgery.
measure: parents satisfaction score.
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, Zagazig University.
state: Alsharkia
Study officials:
affiliation: Faculty of medicine, zagazig university, Egypt
name: Mohammed A Refky, MD
role: STUDY_CHAIR
affiliation: Faculty of medicine, zagazig university, Egypt
name: Doaa M Farid, MD
role: STUDY_CHAIR
affiliation: Faculty of medicine, zagazig university, Egypt
name: Ayat A Amer, MD
role: STUDY_DIRECTOR
References: