Hernia, InguinalNCT03167047
Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
A study testing Caudal block, Nerve Block and Standarising intraoperative pain relief in people with Hernia, Inguinal, run by Dr Kumarvel Veerappan at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Caudal block, Nerve Block and Standarising intraoperative pain relief
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2016to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing day case elective inguinal-scrotal surgery
Who cannot join
- Contraindication to technique
- Significant comorbidities
- Patient/parent refusal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Kumarvel Veerappan, FRCA, 01634 830000 ext. 3722, kumarvel.verrapan@nhs.net
Robert Hughes, MA, 01634 830000 ext. 6782, robert.hughes@medway.nhs.uk
About this study
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.
- Conditions
- Hernia, Inguinal
- Being tested
- Caudal block, Nerve Block, Standarising intraoperative pain relief
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal blockProcedure or surgery
Caudal epidural
Nerve BlockProcedure or surgery
Peripheral nerve block
Standarising intraoperative pain reliefDrug
All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Active comparator | 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 Receives: Procedure: Caudal block; Drug: Standarising intraoperative pain relief |
| Nerve block | Active comparator | 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 Receives: Procedure: Nerve Block; Drug: Standarising intraoperative pain relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
FLACC for preverbal children
Measured: Discharge postoperatively (approximately 2-4 hours postoperatively)
Pain relief
VAS for verbal children
Measured: Discharge postoperatively (approximately 2-4 hours postoperatively)
Secondary outcomes (1)
Motor paresis assessed with the Bromage score
Bromage score
Measured: Discharge postoperatively (approximately 2-4 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Nov 2016
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Kumarvel Veerappan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Kumarvel Veerappan, Medway NHS Foundation Trust
- Investigators
- Kumarvel Veerappan, FRCA, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167047
- Sponsor's protocol ID
- 16/LO/1187
- Status last verified
- May 2017
- First submitted
- 22 Feb 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
- ClinicalTrials.gov ID
- NCT03167047
- Acronym / sponsor ID
- 16/LO/1187
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr Kumarvel VeerappanUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Aug 2017 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block | Active comparator | Procedure: Caudal block, Drug: Standarising intraoperative pain reliefCaudal 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 comparator | Procedure: Nerve Block, Drug: Standarising intraoperative pain reliefPeripheral 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 |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children undergoing day case elective inguinal-scrotal surgery
Key exclusion criteria (3 listed)
- Contraindication to technique
- Significant comorbidities
- Patient/parent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal blockCaudal epidural | Procedure or surgery | Caudal block |
| Nerve BlockPeripheral nerve block | Procedure or surgery | Nerve block |
| Standarising intraoperative pain reliefAll patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg. | Drug | Caudal block, Nerve block |
Primary outcome
Pain relief
Time frame: Discharge postoperatively (approximately 2-4 hours postoperatively)
FLACC for preverbal children
Pain relief
Time frame: Discharge postoperatively (approximately 2-4 hours postoperatively)
VAS for verbal children
1 secondary outcome
Motor paresis assessed with the Bromage score
Time frame: Discharge postoperatively (approximately 2-4 hours postoperatively)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kumarvel Veerappan, FRCA principal investigator
Medway NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal block, Nerve Block and Standarising intraoperative pain relief in people with Hernia, Inguinal, run by Dr Kumarvel Veerappan at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kumarvel Veerappan, FRCA (01634830000 ext. 3722, kumarvel.veerappan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: Discharge postoperatively (approximately 2-4 hours postoperatively)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.