Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Study Overview
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Brief Summary
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Two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). A pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound. One potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that this method is as effective as the use of a regional nerve block.

Official Title
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Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Caudal block
* Procedure: Nerve Block
* Drug: Standarising intraoperative pain relief


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing day case elective inguinal-scrotal surgery Exclusion Criteria: Contraindication to technique Significant comorbidities Patient/parent refusal

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal block<br>Caudal epidural given for post-operative pain relief. Dose used is 1.5ml/kg of weak Levo-Bupivacaine solution (0.125%). Patients will also receive standardised pain relief of paracetamol and fentanyl | Procedure: Caudal block<br>* Caudal epidural<br>Drug: Standarising intraoperative pain relief<br>* All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.<br>|
| Active Comparator: Nerve block<br>Peripheral nerve block given for post operative pain relief. Levo-Bupivacaine 0.25% 2mg/Kg given under ultrasound guidance. Patients will also receive standardised pain relief of paracetamol and fentanyl | Procedure: Nerve Block<br>* Peripheral nerve block<br>Drug: Standarising intraoperative pain relief<br>* All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | FLACC for preverbal children | Discharge postoperatively (approximately 2-4 hours postoperatively) | 
| Pain relief | VAS for verbal children | Discharge postoperatively (approximately 2-4 hours postoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor paresis assessed with the Bromage score | Bromage score | Discharge postoperatively (approximately 2-4 hours postoperatively) |