Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

Study Overview
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Brief Summary
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The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

Detailed Description
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A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia. After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles. After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side . Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg. The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.

Official Title
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Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine 0.125%
* Drug: Bupivacaine 0.25%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II physical status patients. Genders Eligible for Study :male. All children scheduled for laparoscopic surgery between the ages of 1and 5 years. Duration of Laparoscopic procedure not exceeding 90 minutes. Written informed consent from parent of guardian . Exclusion Criteria: Sensitivities to local anesthetics. Significant renal, liver, or cardiac disease. Surgery requiring an open procedure

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>Control | |
| Active Comparator: Group B<br>patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side. | Drug: Bupivacaine 0.125%<br>* Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.<br>* Other names: Plain marcaine;|
| Active Comparator: Group C<br>patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side. | Drug: Bupivacaine 0.25%<br>* Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.<br>* Other names: Plain marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Children's Hospital Eastern Ontario Pain Scale | 12 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative fentanyl consumption | Microgram (ug) | 12 hours postoperative | 
| number of participants with incidence of nausea | number of patients | 12 hours postoperative | 
| number of participants with incidence of hematoma | number of patients | 12 hours postoperative | 
| number of participants with incidence of infection | number of patients | 12 hours postoperative | 
| Total postoperative paracetamol consumption | Milligram (mg) | 12 hours postoperative | 
| Number of participants with incidence of vomiting | number of patients | 12 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block, pediatric, Laparoscopic, postoperative pain