Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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

Trial website

Contact information



Primary contact

Dr Marco Pustetto


Contact details

CHU Grenoble Alpes
Boulevard de la Chantourne
38700 La Tronche
+33 (0)767861931

Additional identifiers

EudraCT number

2016-003918-27 number

Nil known

Protocol/serial number


Study information

Scientific title

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



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;, ref: P2016/404/2016-003918-27

Study design

Interventional single-center randomized double-blinded controlled pilot trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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.


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



Not Applicable

Drug names


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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Total final enrolment


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


Recruitment end date



Countries of recruitment


Trial participating centre

Hôpital Erasme
808, route de Lennik

Sponsor information


Erasmus Hospital

Sponsor details

808 route de Lennik
1070 Bruxelles
+32 (0)2 555 3324

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Erasmus Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data


Basic results (scientific)

Publication list

2020 results in (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.