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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03167047
Other study ID # 16/LO/1187
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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