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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal block | Active Comparator | 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 |
|
| Nerve block | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal block | Procedure | Caudal epidural |
| |
| Nerve Block |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Motor paresis assessed with the Bromage score | Bromage score | Discharge postoperatively (approximately 2-4 hours postoperatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumarvel Veerappan, FRCA | Contact | 01634830000 | 3722 | kumarvel.veerappan@nhs.net |
| Robert Hughes, MA | Contact | 01634 830000 | 6782 | robert.hughes@medway.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Kumarvel Veerappan, FRCA | Medway NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medway NHS Foundation Trust | Recruiting | Gillingham | Kent | ME7 5NY | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 13, 2018 | |
| Unrelease | Aug 14, 2018 | |
| Release | Aug 14, 2018 | |
| Unrelease | Aug 14, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2018 | Aug 14, 2018 | |||
| Aug 14, 2018 | Aug 14, 2018 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| Procedure |
Peripheral nerve block |
|
| Standarising intraoperative pain relief | Drug | All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg. |
|
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |