Condition category
Surgery
Date applied
07/06/2020
Date assigned
15/06/2020
Last edited
25/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims.
Abdominal surgery includes any operation on organs including the stomach, gallbladder, small or large intestine, liver, pancreas, spleen and appendix. Major abdominal surgery is associated with inflammation and damage of the inside layer of blood vessels (called the endothelial glycocalyx). The anti-inflammatory effects of lidocaine, a commonly used local anesthetic, were recently associated with protection of this thin layer. The aim of this study is to find out whether lidocaine can prevent endothelial dysfunction after major abdominal surgery.

Who can participate?
Patients aged 18 or over who are scheduled for major abdominal surgery.

What does the study involve?
Patients are randomly allocated to receive either lidocaine or placebo (dummy drug) during their surgery. Participants undergo three sessions of harmless measurements (before, 1-3 hours and 24 hours after surgery), performed with an ultrasound machine on the right arm and a small electrode on the right hand. A pneumatic cuff will be used to stop blood circulation in the hand for 5 minutes. Three blood tests are associated with these measurements, but they are performed during regular testing before and after surgery without any extra needle insertions.

What are the possible benefits and risks of participating?
Benefits are the presumed reduction in inflammation and thus preservation of the endothelial glycocalyx; and a highly controlled anesthesia protocol with optimization of fluid perfusion and pain reduction. Risks connected to the use of the study drug occur at extremely low frequency at doses used in this study. These are dizziness, metallic taste and a slight reduction in arterial blood pressure.

Where is the study run from?
Erasmus Hospital (Belgium)

When is the study starting and how long is it expected to run for?
December 2016 to March 2017

Who is funding the study?
Erasmus Hospital (Belgium)

Who is the main contact?
Dr Marco Pustetto
marco.pustetto@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marco Pustetto

ORCID ID

https://orcid.org/0000-0002-8738-3280

Contact details

CHU Grenoble Alpes
Boulevard de la Chantourne
38700 La Tronche
Grenoble
38100
France
+33 (0)767861931
mpustetto@chu-grenoble.fr

Additional identifiers

EudraCT number

2016-003918-27

ClinicalTrials.gov number

Nil known

Protocol/serial number

LICAM:2016-003918-27

Study information

Scientific title

Intravenous lidocaine to prevent endothelial dysfunction after major abdominal surgery: a randomized controlled pilot trial

Acronym

LICAM17

Study hypothesis

1. To demonstrate the effects of lidocaine on endothelial glycocalyx flaking in major abdominal surgery
2. To confirm that major abdominal surgery leads to a partial disruption of the endothelial glycocalyx
3. To demonstrate that it is also associated with an alteration of flow-mediated dilation of the brachial artery and of StO₂ of the thenar eminence, measured by NIRS, after a vascular occlusion test
4. To demonstrate that these alterations are related to the level of glycocalyx disruption measured by Syndecan-1
5. To demonstrate that the protection of endothelial glycocalyx leads to a reduction in fluids administered in the peri-operative period following a goal-directed protocol

Ethics approval

Approved 24/10/2016, Erasmus Hospital Ethics Committee (808 route de Lennik, B-1070 Brussels, Belgium; +32 (0)2 555 3707; comite.ethique@erasme.ulb.ac.be), ref: P2016/404/2016-003918-27

Study design

Interventional single-center randomized double-blinded controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients admitted to be operated for major abdominal surgery, i.e. duodeno-cephalo-pancreasectomy, total mesorectal excision, total and partial nephrectomy, total and partial gastrectomy, debulking for ovarian tumeur, total cystectomy.

Intervention

Participants were randomly assigned to one of two groups in a 1:1 ratio, based on Efron’s biased coin randomisation procedure generated with NCSS v10 Statistical Software (2015, NCSS, Llc. Kaysville, UT, USA).

Patients allocated to the intervention group receive 1.5 mg kg-1 (total body weight [TBW]) of 1% lidocaine just before anesthesia induction, which is immediately followed by a 2 mg kg-1 h-1 (TBW) continuous intravenous infusion until skin closure. Patients allocated to the placebo group receive an equivalent volume of 0.9% saline (0.15 ml kg-1 bolus and 0.2 ml kg-1 h-1 continuous intravenous infusion). Anesthesia protocol is standardized in both groups. Hemodynamics are managed with a goal-directed therapy protocol, based on stroke volume variation and mean arterial pressure.

Duration of intervention: from anesthesia induction until skin closure. Duration of follow-up: 24 hours after surgery.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lidocaine

Primary outcome measure

Syndecan-1 concentration measured by classic sandwich enzyme-linked immunosorbent assay at baseline (before surgery), 1-3 h post surgery and 24 h

Secondary outcome measures

1. StO₂-baseline, StO₂-ischemic slope and StO₂-reperfusion slope measured using near-infrared spectroscopy on thenar eminence, before during and after a vascular occlusion test, at baseline (before surgery), 1-3 h post surgery and 24 h
2. Brachial artery baseline diameter, maximal flow-mediated dilation and area under the curve of estimated shear rate of hyperaemic flow measured by ultrasonography of the brachial artery coupled with an automated edge detection software, before during and after a vascular occlusion test, at baseline (before surgery), 1-3 h post surgery and 24 h

Overall trial start date

01/07/2016

Overall trial end date

30/04/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. Planned major abdominal surgery: duodeno-cephalo-pancreasectomy, total mesorectal excision, total and partial nephrectomy, total and partial gastrectomy, debulking for ovarian tumour, total cystectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Total final enrolment

40

Participant exclusion criteria

1. Urgent surgery
2. Severe heart conduction block without implantable pacemaker
3. Severe liver and kidney insufficiency
4. Major liver resection
5. Acute heart failure
6. Allergic reaction to lidocaine or other amide-linked local anesthetics

Recruitment start date

01/12/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

Belgium

Trial participating centre

Hôpital Erasme
808, route de Lennik
Bruxelles
1070
Belgium

Sponsor information

Organisation

Erasmus Hospital

Sponsor details

808 route de Lennik
1070 Bruxelles
Bruxelles
1070
Belgium
+32 (0)2 555 3324
Secmed.anestrea@erasme.ulb.ac.be

Sponsor type

Hospital/treatment centre

Website

https://www.erasme.ulb.ac.be/fr

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32576151/ (added 25/06/2020)

Publication citations

Additional files

Editorial Notes

25/06/2020: Publication reference added. 12/06/2020: Trial's existence confirmed by Erasmus Hospital Ethics Committee.