Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.

Detailed Description
-----------------
In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled. A written informed consent from all parents are obtained

Official Title
-----------------
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: ultra-sound guided transversus abdominis plan block
* Drug: magnesium sulphate& levobupivacaine
* Drug: Levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled. Exclusion Criteria: Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: magnesium sulphate& levobupivacaine<br>Levobupivacaine add to magnisum sulphate | Procedure: ultra-sound guided transversus abdominis plan block<br>* comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine<br>Drug: magnesium sulphate& levobupivacaine<br>* magnesium sulphate& levobupivacaine<br>|
| Placebo Comparator: levobupivacaine<br>levobupivacaine | Procedure: ultra-sound guided transversus abdominis plan block<br>* comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine<br>Drug: Levobupivacaine<br>* levobupivacaine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain management | pain will be assessed using FLACC score.The Face, Legs, Activity, Cry, Consolability (FLACC) pain score with its 0 - 10 score range will be used to assess pain immediately postoperative and then at 2, 4, 6, 8, 12, 18 and 24 hours in the postoperative period. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAP, magnisum sulphate