Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

NCT ID: NCT03167047

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Caudal block

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

Group Type ACTIVE_COMPARATOR

Caudal block

Intervention Type PROCEDURE

Caudal epidural

Standarising intraoperative pain relief

Intervention Type DRUG

All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.

Nerve block

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

Group Type ACTIVE_COMPARATOR

Nerve Block

Intervention Type PROCEDURE

Peripheral nerve block

Standarising intraoperative pain relief

Intervention Type DRUG

All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.

Interventions

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Caudal block

Caudal epidural

Intervention Type PROCEDURE

Nerve Block

Peripheral nerve block

Intervention Type PROCEDURE

Standarising intraoperative pain relief

All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria

* Contraindication to technique
* Significant comorbidities
* Patient/parent refusal
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Kumarvel Veerappan

OTHER

Sponsor Role lead

Responsible Party

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Dr Kumarvel Veerappan

Consultant Paediatric Anaesthatist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kumarvel Veerappan, FRCA

Role: PRINCIPAL_INVESTIGATOR

Medway NHS Foundation Trust

Locations

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Medway NHS Foundation Trust

Gillingham, Kent, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Kumarvel Veerappan, FRCA

Role: CONTACT

01634830000 ext. 3722

Robert Hughes, MA

Role: CONTACT

01634 830000 ext. 6782

Facility Contacts

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Kumarvel Veerappan, FRCA

Role: primary

01634 830000 ext. 3722

Robert Hughes, MA

Role: backup

01634 830000 ext. 6782

Other Identifiers

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16/LO/1187

Identifier Type: -

Identifier Source: org_study_id

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