The effect of local anaesthetic on pain following oral surgery under general anaesthetic

ISRCTN	ISRCTN84216266
DOI	https://doi.org/10.1186/ISRCTN84216266
EudraCT/CTIS number	2008-000254-13
Secondary identifying numbers	RD/613/07

Submission date: 11/12/2008
Registration date: 23/01/2009
Last edited: 10/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Michael Murphy
Scientific

Department of Oral and Maxillofacial Surgery
Royal Gwent Hospital
Newport
NP20 2UB
United Kingdom

Email	mike.murphy@gwent.wales.nhs.uk

Study information

Study design	Double-blind randomised placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on post-operative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment
Study objectives	Intra-operative administration of local anaesthetic significantly reduces post-operative pain experience in children aged 12 to 16 years having ambulatory oral surgery to facilitate orthodontic treatment under general anaesthetic.
Ethics approval(s)	South East Wales REC Panel B, 14/10/2008, ref: 08/WSE02/57
Health condition(s) or problem(s) studied	Pain following ambulatory oral surgery
Intervention	Treatment group: standard dental local anaesthetic in the form 2% lidocaine hydrochloride with 1 in 80000 adrenaline by local injection Control group: saline by local injection Treatment takes place on a single day. No follow-up.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lidocaine hydrochloride
Primary outcome measure	Post-surgical pain using a Visual Analogue Scale, measured pre-surgery, at 30 minutes, 1 hour and 2 hours post-surgery.
Secondary outcome measures	Measurement of time to rescue analgesia.
Overall study start date	20/02/2009
Completion date	20/02/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	68
Key inclusion criteria	1. Aged 12 to 16 years, either sex 2. Requiring surgery necessitating the raising of a mucoperiosteal flap and bone removal in at least one but not more than two sites 3. Suitable for ambulatory surgery
Key exclusion criteria	1. Age under 12 years 2. History of allergy to local anaesthetic of the amide type or to any components of the injectable formulation, paracetamol or non-steroidal anti-inflammatory drugs Exclusion criteria due to the presence of adrenaline in the local anaesthetic formula: 3. Arterial hypertension 4. Coronary disease 5. Valvular heart disease Standard anaesthetic-based exclusions for ambulatory surgery: 6. American Society of Anaesthesiologists (ASA) grade greater than 2 7. Body mass index greater than 35 8. Poorly controlled asthma
Date of first enrolment	20/02/2009
Date of final enrolment	20/02/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Royal Gwent Hospital

Newport
NP20 2UB
United Kingdom

Sponsor information

Gwent Healthcare NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
The Friars
Newport
NP20 4EZ
Wales
United Kingdom

Email	mike.murphy@gwent.wales.nhs.uk
Website	http://www.wales.nhs.uk/sites3/home.cfm?orgid=79
"ROR"	https://ror.org/045gxp391

Funders

Funder type

Government

Gwent Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator