Evaluation of the use of the local anaesthetic drug lidocaine to decrease pain and opioid doses in burned patient when given as intravenous infusion

ISRCTN	ISRCTN16172216
DOI	https://doi.org/10.1186/ISRCTN16172216
Secondary identifying numbers	Xylocard 001

Submission date: 19/11/2017
Registration date: 08/01/2018
Last edited: 08/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Treating of background pain in burned patients is difficult and requires high doses of opioids (pain relief medications) which often results in unfavorable symptoms and sometimes a life threatening complications such as respiratory depression. Intravenous administration (inserting liquids directly into a vein) of lidocaine (a type of opioid) showed a good effect in treating pain in burns. It has a peripheral and central effect on pain receptors with a significant decrease in release of prostaglandin E for burns in vivo, which is considered one of the most important mediators for peripheral pain. The aim of this study is to compare the opioids sparing effect among patients who received lidocaine IV infusion with that of those who received a placebo (normal saline).

Who can participate?
Adults aged 18 to 70 with burns that are more than 10 percent of their total body surface area .

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the interventional drug of lidocaine intravenously through a vein, this is continued for seven days. Those in the second group receive normal saline for seven days.

What are the possible benefits and risks of participating?
The patients who were given lidocaine can benefit from the decreased pain killer doses. Adverse effects were meticulously monitored and dealt with immediately. Participants are followed up to measure their opioid consumption and pain levels at baseline, days 1-3 and days 4-6.

Where is the study run from?
Linkoping Burn Center (Sweden)

When is the study starting and how long is it expected to run for?
Jan 2003 to April 2017

Who is funding the study?
Linkoping University (Sweden)

Who is the main contact?
Professor Folke Sjoberg
folke.sjoberg@liu.se

Contact information

Prof Folke Sjoberg
Public

Burn Centre
University Hospital in Linkoping
Linkoping
58185
Sweden

ORCID ID	0000-0002-5903-2918
Phone	+46 (0)101 031820
Email	folke.sjoberg@liu.se

Study information

Study design	Single-centre double-blinded three block randomised controlled trial
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	Effect of intravenous infusion of Xylocard on morphine consumption among patients with burns > 10% TBSA
Study objectives	Intravenous infusion of lidocain will results in decreased opioid consumption in burned patients.
Ethics approval(s)	The Linköping Ethical Review Board, 2003/03/11, ref. (03-073)
Health condition(s) or problem(s) studied	Pain in burned patients
Intervention	Participants are randomly allocated to one of two groups: the intervention group or the control group. Interventional drug: intravenous infusion of lidocaine starting with bolus dose 1 mg/kg, followed by lidocaine infusion 6o ml/hour for four hours 4mg/ml, then continuous infusion 45 ml/hour 4mg/ml for seven days. Control Group: Equivalent volume of 0.9% Sodium Chloride starting with bolus dose, followed by lidocaine infusion 6o ml/hour for four hours, then continuous infusion 45 ml/hour for seven days. Participants are followed up to measure their opioid consumption and pain levels at baseline, days 1-3 and days 4-6.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Xylocard : lidocaine, AstraZeneca
Primary outcome measure	Opioid consumption (intravenous and oral in milligram/day) is measured using the recordings from both infusion pump and nurses’ written doses administered at baseline day 0, days 1-3 and days 4-6.
Secondary outcome measures	Pain is measured using the visual analogue scale (measured six times per day) at baseline day 0, days 1-3 and days 4-6.
Overall study start date	18/01/2003
Completion date	04/10/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	25
Key inclusion criteria	1. Burns more than 10 Total body surface area (tbsa) 2. Aged between 18 and 70 years 3. Adminstration of patient controlled anaglesia (morphine)
Key exclusion criteria	1. Untreated AV-block type II or III 2. Known heart failure 3. Known allergy to local anaesthesia 4. Liver cirrhosis and severe renal dysfunction
Date of first enrolment	11/07/2005
Date of final enrolment	10/09/2014

Locations

Countries of recruitment

Sweden

Study participating centre

Linkoping Burn Center

Linkoping University Hospital
Linkoping
58185
Sweden

Sponsor information

Linkoping University
University/education

Garnsionsgatan
Linkoping
58185
Sweden

Phone	+46 (0)101 030 000
Email	liu@liu.se
Website	www.liu.se
"ROR"	https://ror.org/05ynxx418

Funders

Funder type

University/education

Linköpings Universitet
Government organisation / Local government

Alternative name(s): Linköping University, Linköping University, LiU
Location: Sweden

Results and Publications

Intention to publish date	10/01/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The participant level data consists of anonymous numbers in a data sheet, which is stored within the data security system of the hospital where the researchers are working. There is no web link available as the security system does not allow external visitors. The process for requesting access can be initiated by the use of the contact details below. Consent from participants was obtained for publication of the analysed results of the study. No consent was obtained for distributing individual data to external interests.