Back to resultsPost-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
Primary Purpose
Hernia, Inguinal
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Caudal block
Nerve Block
Standarising intraoperative pain relief
Sponsored by
About this trial
This is an interventional supportive care trial for Hernia, Inguinal
Eligibility Criteria
Inclusion Criteria:
- Children undergoing day case elective inguinal-scrotal surgery
Exclusion Criteria:
- Contraindication to technique
- Significant comorbidities
- Patient/parent refusal
Sites / Locations
- Medway NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Caudal block
Nerve block
Arm Description
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
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
Outcomes
Primary Outcome Measures
Pain relief
FLACC for preverbal children
Pain relief
VAS for verbal children
Secondary Outcome Measures
Motor paresis assessed with the Bromage score
Bromage score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03167047
Brief Title
Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
Official Title
Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Anticipated)
Study Completion Date
August 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Kumarvel Veerappan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caudal block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nerve block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Caudal block
Intervention Description
Caudal epidural
Intervention Type
Procedure
Intervention Name(s)
Nerve Block
Intervention Description
Peripheral nerve block
Intervention Type
Drug
Intervention Name(s)
Standarising intraoperative pain relief
Intervention Description
All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.
Primary Outcome Measure Information:
Title
Pain relief
Description
FLACC for preverbal children
Time Frame
Discharge postoperatively (approximately 2-4 hours postoperatively)
Title
Pain relief
Description
VAS for verbal children
Time Frame
Discharge postoperatively (approximately 2-4 hours postoperatively)
Secondary Outcome Measure Information:
Title
Motor paresis assessed with the Bromage score
Description
Bromage score
Time Frame
Discharge postoperatively (approximately 2-4 hours postoperatively)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children undergoing day case elective inguinal-scrotal surgery
Exclusion Criteria:
Contraindication to technique
Significant comorbidities
Patient/parent refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kumarvel Veerappan, FRCA
Phone
01634830000
Ext
3722
Email
kumarvel.veerappan@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Hughes, MA
Phone
01634 830000
Ext
6782
Email
robert.hughes@medway.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumarvel Veerappan, FRCA
Organizational Affiliation
Medway NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medway NHS Foundation Trust
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kumarvel Veerappan, FRCA
Phone
01634 830000
Ext
3722
Email
kumarvel.verrapan@nhs.net
First Name & Middle Initial & Last Name & Degree
Robert Hughes, MA
Phone
01634 830000
Ext
6782
Email
robert.hughes@medway.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
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