Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics

Study Overview
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Brief Summary
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This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry, Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to observe the side effects of these techniques such as nausea, vomiting, bradycardia, hypotension, respiratory depression.

Detailed Description
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Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is considered the gold standart regional technique for pain management after lower abdominal surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform caudal block, demostrating cannule placement and precise deposition of local anesthetic in the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1 dermatomes and provides postoperative pain relief after lower abdominal surgery with lower complication rate rather than caudal block but it may not prevent traction on the peritoneal sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain due to incision after 2 months.

Official Title
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A Prospective Randomized Trial Comparing Analgesic Effects of Three Ultrasound-guided Regionel Anesthetic Techniques in Pediatrics: Caudal Analgesia, Transversus Abdominis Plane and Quadratus Lumborum Blocks

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing lower abdominal surgery ASA(American Society of Anestesiology)1-2 Exclusion Criteria: denial of patient or parents, infection on the local anesthetic application area infection in central nervous system coagulopathy brain tumours known allergy against local anesthetics anatomical difficulties with preexisting cardiac dysfunction with history of renal and/or hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum Block<br>US-guided quadratus lumborum block will be performed with 0,5 ml/kg 0.25% Bupivacaine in the anterior layer of the thoracolumbar fascia between psoas major and quadratus lumborum muscles | Drug: Bupivacaine<br>* % 0,25<br>* Other names: Marcaine;|
| Active Comparator: Transversus Abdominis Plane Block<br>US- guided transversus abdominis plane block will be performed with 0,5 ml/kg 0.25% Bupivacaine into the fascial plane between internal oblique muscle and transversus abdominis muscle | Drug: Bupivacaine<br>* % 0,25<br>* Other names: Marcaine;|
| Active Comparator: Caudal Block<br>US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL | Drug: Bupivacaine<br>* % 0,25<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs Activity, Cry, Consolability (FLACC) scores | It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain. | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospitalisation | Through study completion, an average of 1 week | 
| Number of patients who require rescue analgesic | Number of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours | up to 48 hours | 
| First analgesic requirement time | Duration of postoperative analgesia | Up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadratus lumborum block, transversus abdominis plane block, caudal block, ultrasound-guided