Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery

Study Overview
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Brief Summary
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Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Detailed Description
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Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Official Title
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Comparing Analgesic Effects of Ultrasound-Guided Caudal and Erector Spinae Plane Blocks in Pediatric Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Double-Blinded Study

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Bupivacaine 0.7 ml/kg
* Drug: Bupivacaine 0.5 ml/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing upper abdominal surgery ASA(American Society of Anesthesiology)1-2 Exclusion Criteria: denial of patient or parents infection on the local anesthetic application area infection in the central nervous system coagulopathy brain tumors 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: 1 Year
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: Caudal Block<br>US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine | Drug: Bupivacaine 0.7 ml/kg<br>* Bupivacaine 0.25% 0.7 ml/kg<br>* Other names: Marcaine;|
| Active Comparator: Erector Spinae Plane Block<br>US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine | Drug: Bupivacaine 0.5 ml/kg<br>* Bupivacaine 0.25% 0.5 ml/kg<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale | Pain scores between 0-10 | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | hospitalisation | through study completion, an average of 1 week | 
| number patients who require rescue analgesic | number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours | up to 48 hours | 
| Time to first analgesic | Duration of postoperative analgesia | up to 48 hours | 
| Incidence of side effects/complications | hematoma, dural puncture, infections | up to first week | 
| Time to first mobilization | time to first mobilization | up to 48 hours | 
| Presence of pain (chronic pain - Visual Analog scale>3) | Chronic pain due to incision after 2-3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector Spinae Plane Block, Caudal Block, Ultrasound guidance, Postoperative analgesia, Upper abdominal surgery