Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Study Overview
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Brief Summary
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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 analgesia for approximately 4-6 hours. Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Detailed Description
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The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia. -Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol). 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 analgesia for approximately 4-6 hours. Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Official Title
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Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
* Drug: caudal plain bupivacaine 2.5mg/kg 0.25%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 2-12 years. Weight: 15-40 kg. Sex: both males and females. ASA physical status: 1-II. Operation: surgery below umbilicus. Exclusion Criteria: Allergic reaction to local anesthetics (LAs). Local or systemic infection (risk of meningitis). Coagulopathy. Intracranial hypertension. Hydrocephalus. Intracranial hemorrhage. Parental refusal. Hypovolemia. 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: 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: Spinal group<br>Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad. be given by . | Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%<br>* The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.<br>* Other names: Marcain;|
| Active Comparator: Caudal group<br>caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance give or pop will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper. | Drug: caudal plain bupivacaine 2.5mg/kg 0.25%<br>* The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance give or pop will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.<br>* Other names: Bucain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC Score | FLACC scores will be recorded. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of rescue analgesics | The total consumption of postoperative rescue analgesics will be recorded. | 24 hours | 
| Postoperative Agitation | Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale. | 60 min. | 
| Adverse effects | Any adverse effect will be treated and recorded. | 24 hours | 
| Residual motor paralysis | By the Modified Bromage scale | 6 hours |