Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

Study Overview
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Brief Summary
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This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.

Official Title
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Comparison of Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

Conditions
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Conventional Caudal Block, Ultrasound Guided Caudal Block, Ultrasound Guided Erector Spinae Block, Pediatric Hip Surgery

Intervention / Treatment
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* Procedure: Conventional caudal block
* Procedure: Ultrasound-guided caudal block
* Procedure: Ultrasound guided erector spinae plane Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sex ASA physical activity I, II Age 4-12 years Admitted for elective hip surgery. Exclusion Criteria: Parents refusal Children with severe systemic disease ASA III or IV Children with previous neurological or spinal anomaly, coagulation disorders History of premature birth Infection at the block injection site History of allergy to local anesthetics Bilateral hip surgery.

Ages Eligible for Study
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Minimum Age: 4 Years
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional caudal block<br>Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block | Procedure: Conventional caudal block<br>* Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).<br>|
| Experimental: Ultrasound-guided caudal block<br>Patients of this group will receive caudal block using ultrasound. | Procedure: Ultrasound-guided caudal block<br>* Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).<br>|
| Experimental: Ultrasound guided erector spinae plane Block<br>Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) . | Procedure: Ultrasound guided erector spinae plane Block<br>* Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pain intensity | To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain) | First 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean arterial blood pressure | Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h). | Intraoperative and first 24 hours postoperative | 
| Changes in heart rate | Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h). | Intraoperative and first 24 hours postoperative | 
| Amount of Analgesic required in the first day after surgery | The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score > 4. | First 24 hours postoperative | 
| Time to first rescue analgesic demand after surgery. | measured from the end of surgery till patient require analgesia. | First 24 hours postoperative | 
| Success rate of block | a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not>20% of the basal levels. If the increase is>20%, the block is accepted as unsuccessful. | Intraoperative duration | 
| Duration of performing the block | Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration | Intraoperative duration | 
| Incidence of complications | Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST). | Intraoperative and first 24 hours postoperative |