Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedMay 25, 2017
May 1, 2017
8 months
February 22, 2017
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Motor paresis assessed with the Bromage score
Discharge postoperatively (approximately 2-4 hours postoperatively)
Study Arms (2)
Caudal block
ACTIVE COMPARATORCaudal 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 COMPARATORPeripheral 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
Interventions
All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.
Eligibility Criteria
You may qualify if:
- Children undergoing day case elective inguinal-scrotal surgery
You may not qualify if:
- Contraindication to technique
- Significant comorbidities
- Patient/parent refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kumarvel Veerappan, FRCA
Medway NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant Paediatric Anaesthatist
Study Record Dates
First Submitted
February 22, 2017
First Posted
May 25, 2017
Study Start
November 1, 2016
Primary Completion
June 30, 2017
Study Completion
August 30, 2017
Last Updated
May 25, 2017
Record last verified: 2017-05