Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children

Study Overview
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Brief Summary
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Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been thoroughly studied, and a large global experience exists.

Detailed Description
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Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned. Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for approximately 4-6 hours.

Official Title
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Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial

Conditions
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Pain, Postoperative, Analgesia

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 2-10 years. Weight: 15-40 kg. Sex: both males and females. ASA physical status: 1-II. Operation: surgery below the umbilicus. Exclusion Criteria: Allergic reaction to local anesthetics (LAs). Local or systemic infection (risk of meningitis). Intracranial hypertension. Hydrocephalus. Intracranial hemorrhage. Coagulopathy. Hypovolemia. Parental refusal. Spinal deformities, such as spina bifida or myelomeningocele. Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spinal group<br>Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg | Drug: Levobupivacaine<br>* Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg<br>* Other names: levobupivacaine hydrate;|
| Active Comparator: caudal group<br>Plain, isobaric levobupivacaine (0.25%) 1 ml/kg | Drug: Levobupivacaine<br>* Plain, isobaric levobupivacaine (0.25%) 1 ml/kg<br>* Other names: Levobupivacaine hydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded | Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10). | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of rescue analgesics | mg/24 | 24 hours |