Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Caudal block; Procedure: Nerve Block; Drug: Standarising intraoperative pain relief

• Registration Number: NCT03167047
• Lead Sponsor: Dr Kumarvel Veerappan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-02-22
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-23
• Study First Posted: 2017-05-25
• Last Update Posted: 2017-05-25
• Primary Completion: 2017-06-30
• Study Completion: 2017-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria

• Contraindication to technique
• Significant comorbidities
• Patient/parent refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block	Caudal block	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
Caudal block	Standarising intraoperative pain relief	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	Nerve Block	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
Nerve block	Standarising intraoperative pain relief	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

Primary Outcome Measures

Name	Time	Method
Pain relief	Discharge postoperatively (approximately 2-4 hours postoperatively)	VAS for verbal children

Secondary Outcome Measures

Name	Time	Method
Motor paresis assessed with the Bromage score	Discharge postoperatively (approximately 2-4 hours postoperatively)	Bromage score

Trial Locations

Locations (1)

Medway NHS Foundation Trust; 🇬🇧 Gillingham, Kent, United Kingdom