The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block

Study Overview
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Brief Summary
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This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery. Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

Detailed Description
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The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.

Official Title
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The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-

Conditions
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Postoperative Pain, Inguinal Hernia Unilateral, Children, Only

Intervention / Treatment
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* Drug: Transversalis Fascia Plane Block
* Drug: Ilioinguinal/iliohypogastric Nerve Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients undergoing unilateral open hernia repair surgery Exclusion Criteria: known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 13 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transversalis Fascia Plane Block<br>receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. | Drug: Transversalis Fascia Plane Block<br>* block will be performed under real-time ultrasound guidance<br>* Other names: TFPB;|
| Active Comparator: Ilioinguinal/iliohypogastric Nerve Block<br>receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. | Drug: Ilioinguinal/iliohypogastric Nerve Block<br>* block will be performed under real-time ultrasound guidance<br>* Other names: II/IH B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking appearance | scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain) | 3 to 5 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC (face, legs, activity, cry, consolability) score | behavioral pain scale in children. Each category has 0 to 2 score; Total 0 (no pain) to 10 (worst) | 3 to 5 hours after surgery | 
| Faces Pain Scale revised | self-reported pain score. Children choose a face from six faces. | 3 to 5 hours after surgery | 
| additional pain curer usage | request or necessity of administration of acetaminophen or flurbiprofen | up to 5 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversalis fascia, ilioinguinal/iliohypogastric nerve, inguinal hernia repair, children