Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

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 Overview

• Status: Unknown
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Procedure: Caudal block; Drug: Standarising intraoperative pain relief; Procedure: Nerve Block

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Recruiting
      • Medway NHS Foundation Trust
      • Contact: Robert Hughes, MA; Phone Number: 6782 01634 830000; Email: robert.hughes@medway.nhs.uk
      • Contact: Kumarvel Veerappan, FRCA; Phone Number: 3722 01634 830000; Email: kumarvel.verrapan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria:

• Contraindication to technique
• Significant comorbidities
• Patient/parent refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Procedure: Caudal block; Caudal epidural; Drug: Standarising intraoperative pain relief; All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.
ACTIVE_COMPARATOR: 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	Drug: Standarising intraoperative pain relief; All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.; Procedure: Nerve Block; Peripheral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor paresis assessed with the Bromage score	Bromage score	Discharge postoperatively (approximately 2-4 hours postoperatively)

Collaborators and Investigators

• Sponsor: Dr Kumarvel Veerappan
• Investigators: Principal Investigator: Kumarvel Veerappan, FRCA, Medway NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ANTICIPATED): June 30, 2017
• Study Completion (ANTICIPATED): August 30, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (ACTUAL): May 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Inguinal
• Other Study ID Numbers: 16/LO/1187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No