Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Hernia, Inguinal Clinical Trial

Official title:

Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167047
• Other study ID #: 16/LO/1187
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: May 23, 2017
• Start date: November 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: May 2017
• Source: Medway NHS Foundation Trust
• Contact: Kumarvel Veerappan, FRCA
• Phone: 01634830000
• Email: kumarvel.veerappan[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

Inclusion Criteria:

• Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria:

• Contraindication to technique

• Significant comorbidities

• Patient/parent refusal

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain, Postoperative

Intervention

Procedure:
• Caudal block
Caudal epidural
• Nerve Block
Peripheral nerve block

Drug:
• Standarising intraoperative pain relief
All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.

Locations

Country	Name	City	State
United Kingdom	Medway NHS Foundation Trust	Gillingham	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Dr Kumarvel Veerappan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	FLACC for preverbal children	Discharge postoperatively (approximately 2-4 hours postoperatively)
Primary	Pain relief	VAS for verbal children	Discharge postoperatively (approximately 2-4 hours postoperatively)
Secondary	Motor paresis assessed with the Bromage score	Bromage score	Discharge postoperatively (approximately 2-4 hours postoperatively)