Condition category
Signs and Symptoms
Date applied
16/07/2019
Date assigned
18/07/2019
Last edited
10/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cleft lip and/or cleft palate occurs in about 1 in 700 births worldwide, although the incidence varies widely across populations. The incidence in Ireland is about 1 in 625 live births, of which half are isolated cleft palate and half are cleft lip with or without cleft palate. Cleft plate repairs can be painful after surgery and satisfactory pain management can be challenging. Injection of long-acting local anaesthetic into the palatal tissues during surgery is routinely used in order to reduce the need for opioid medication after surgery. However, a local anaesthetic nerve block may provide more effective pain relief after surgery, reducing the need for opioids, allowing earlier feeding and discharge from recovery and hospital and reducing the use of intensive care or high dependency facilities. The aim of this study is to determine if pain relief is better with both general anaesthetic and local anaesthetic or general anaesthetic alone in cleft palate repair surgery.

Who can participate?
Patients who underwent cleft palate surgery with general anaesthetic and local anaesthetic or just general anaesthetic

What does the study involve?
Data is collected on patients who have already undergone cleft palate surgery and had general anaesthesia and local anaesthetic block. Data includes pain scores, analgesia requirements during and after surgery, adverse effects of regional blocks, time to first feed, time to discharge from recovery and time to discharge from hospital. This data is compared with similar data available for a previous group of patients who had palate repair before the introduction of local anaesthetic.


What are the possible benefits and risks of participating?
This study will provide evidence that local anaesthetic is beneficial or that it is not as good as believed. Use of local anaesthetic may help to reduce pain, the need for opioids, time to first feed, and discharge times by providing more effective pain relief. It may also allow savings in hospital costs by reducing the requirements for higher levels of care and allowing earlier discharges. There are no risks in participating in study as surgeries have already been carried out.

Where is the study run from?
Our Lady’s Children’s Hospital Crumlin (Ireland)

When is the study starting and how long is it expected to run for?
September 2017 to January 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Orla Kerr
orlakerr@doctors.org.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Orla Kerr

ORCID ID

Contact details

3 Aughrim Road
Kilkeel
Newry
BT344HR
United Kingdom
+44 (0)894979754
orlakerr@doctors.org.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Bilateral maxillary nerve blocks via a suprazygomatic approach to the pterygopalatine fossa for pain relief in cleft palate repairs: a comparative study of general anaesthesia combined with bilateral maxillary nerve blocks via a suprazygomatic approach to the pterygopalatine fossa with 0.25% levobupivacaine, versus general anaesthesia alone on pain management in cleft palate repairs

Acronym

Study hypothesis

A previous prospective-retrospective audit of suprazygomatic blocks versus GA4 and a recent randomised control trial of bilateral maxillary blocks via the suprazygomatic approach has provided evidence that PPMB is safe and has been shown to reduce opioid consumption post-operatively. This block has been implemented by some of the anaesthetic consultants in Our Ladys Childrens Hospital Crumlin already, given this evidence. Implementation of this block has been found to have positive post-operative pain effects, although these effects have not been audited. Both Consultant Anaesthetists and Surgeons believe this block is safe and is an improvement on existing techniques with beneficial effects on pain relief postoperatively. It is therefore not possible to conduct a randomized control trial, as there is not sufficient equipoise to withhold this block from a control group. The researchers will therefore conduct a two-stage study. The first stage, the retrospective part, will be a service review where the researchers will use audit techniques and mathematical analysis to find the historic opioid use, time to discharge and time to 1st feed in unselected palate repairs without bilateral PPMB. The second part will be a prospective analysis of a change in practice without randomization in which the researchers will make the same measurements after the introduction of bilateral PPMB.

Hypothesis: Bilateral PPMB with 0.25% levobupivacaine has no effect on pain scores, intra- and post-operative analgesic requirements, time to first feed or discharge times.

Ethics approval

Approved 11/09/2018, Ethics (Medical Research) Committee (Our Lady's Hospital Crumlin, Dublin D12 N512 Ireland; Tel: +353 (0)1 409 6307/6243)

Study design

Two-stage study: retrospective group and prospective group since regional block introduction

Primary study design

Observational

Secondary study design

Two-stage study: retrospective group and prospective group since regional block introduction

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cleft palate repair pain management

Intervention

The researchers will be retrospectively recording data on primary and secondary outcomes in a group who underwent general anaesthetic and local anaesthetic and those who just had general anaesthetic in a group who underwent cleft palate surgeries.

Data will be collected intraoperatively in recovery, on the ward until discharge and at the 1st outpatient appointment, which is roughly 6 weeks post-surgery.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Postoperative opiate consumption at 48 hours and to discharge, measured from patients' medical records

Secondary outcome measures

Measured from patients' medical records:
1. Postoperative pain scores assessed by FLACC up to 48 hours
2. Intra- and post-operative analgesia requirements until discharge (mg)
3. Time to first analgesic requirement
4. Time to first feed (time taken to establish milk feed following an initial trial of water or milk)
5. Time to discharge from recovery and hospital
6. Adverse events (to discharge and at 1st 6-week outpatient appointment)
7. Block problems (to discharge and at 1st 6-week outpatient appointment)
8. Postoperative nausea and vomiting
9. Airway complications (reported to discharge)

Overall trial start date

28/09/2017

Overall trial end date

01/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All cleft palate primary repairs +/- lip repairs
2. Secondary cleft palate repairs +/- lip repairs

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50 in each arm

Participant exclusion criteria

1. Local anaesthetic allergy
2. Bleeding disorders
3. Cutaneous infection
4. Solo cleft lip repairs

Recruitment start date

01/07/2019

Recruitment end date

01/08/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Our Lady’s Children’s Hospital Crumlin
Cooley Road Drimnagh
Dublin
Dublin 12
Ireland

Sponsor information

Organisation

Our Lady's Hospital Crumlin

Sponsor details

Cooley Road
Drimnagh
Dublin
Dublin 12
Ireland
+353 (0)1 4096100
human.resources@olchc.ie

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study results may be presented locally, peer review and in academic journals but no identifying data will be used.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/09/2019: The following changes were made to the trial record: 1. The intention to publish date was changed from 01/01/2020 to 01/06/2020. 2. The total final enrolment was added. 18/07/2019: Trial's existence confirmed by Ethics (Medical Research) Committee.