Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

Study Overview
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Brief Summary
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The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients

Official Title
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Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study

Conditions
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Post Operative Pain

Intervention / Treatment
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* Procedure: erector spinea block
* Procedure: Caudal epidural block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II. Scheduled to undergo hip or proximal femur surgeries. Exclusion Criteria: Refusal of participation by parents or caregivers Known local anesthetic (LA) drug sensitivity Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3. Skin lesions or wounds at the site of proposed needle insertion.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 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: group ESPB<br>Erector Spinae Plane Block | Procedure: erector spinea block<br>* the patients will receive a single injection erector spinea block after induction of general anesthesia<br>|
| Active Comparator: In group CEA<br>Caudal epidural block | Procedure: Caudal epidural block<br>* the patients will receive caudal epidural block after induction of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | By using face, legs, activity, and cry consolability scale [FLACC ] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain | 2 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | By using face, legs, activity, and cry consolability scale [FLACC ] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain | at 2 hour intervals during the first 24 hours postoperatively | 
| Block failure rate | The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively | First hour postoperatively | 
| Block performance time |  | Preoperative | 
| The incidence of adverse effects |  | Up to one week after the block | 
| Duration of the block |  | UP to 48 hours postoperatively | 
| Degree of contralateral motor blockage and lower limb weakness | By using modified bromage scale as following: Grade I : Free movement of legs and feet Degree of block :Nil (0%) Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%) Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%) Grade IV :Unable to move legs or feet Degree of block: Complete (100%) | UP to 48 hours postoperatively |