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Impact of Intra- and Postoperative Continuous Infusion of Lidocaine on Analgesia in Vascular Anaesthesia

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ClinicalTrials.gov Identifier: NCT04691726
Recruitment Status : Suspended (Pandemia of the Covid-19)
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Łukasz Krzych, Medical University of Silesia

Brief Summary:

The aim of the study is to test the effectiveness and safety of the use of lidocaine infusion in multimodal analgesic management. A group of patients undergoing vascular surgery performed with the classic technique on the aorta - with the opening of the abdominal cavity will be enrolled. The population of patients qualified for this type of vascular surgery is usually burdened with multiple diseases, mainly risk factors or cardiovascular diseases, which, combined with hemodynamic fluctuations, large fluid shifts (including bleeding) and stress for the body, affects the risk of serious cardiological complications, which in this group exceeds 5% and is the highest, according to the ESC / ESA (European Society of Cardiology / European Society of Anesthesiology) classification from 2014. Proper postoperative pain control is therefore becoming one of the key pillars of postoperative care in this group of patients.

Due to the numerous disease burden of patients and the operational specifics, the use of multimodal therapy in the management of pain is of particular importance, as the use of high doses of opioids improves hemodynamic stability, but at the same time affects the occurrence of side effects - mainly excessive sedation, respiratory disorders, hypoventilation and, consequently, for hypoxia of the heart muscle. The risk of myocardial injury in non-cardiac surgery (MINS) is significant in the light of the available literature.

Lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. Its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects. The high effectiveness of such a procedure has been proven in numerous experimental and epidemiological studies. Due to the low frequency of side effects associated with its use, the therapy has a strong recommendation for use in relieving perioperative pain. The analysis of the literature on the subject shows that there is little data assessing effectiveness of lidocaine infusion in relation to the group of patients after surgery on the abdominal aorta.


Condition or disease Intervention/treatment Phase
Abdominal Aorta Aneurysm Abdominal Aorta Atheroma Surgery Pain, Postoperative Drug: lidocaine 10mg/ml Drug: Placebo Drug: Metamizole Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Single-centre Clinical Trial Evaluating Efficacy and Safety of Intraoperative and Postoperative Continuous Lidocaine Infusion in High Cardiac Risk Vascular Surgery
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine infusion
Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 2 mg/kg IBW i.v., continuous infusion of 1% lidocaine postoperatively rate 1 mg/kg IBW i.v. for 24 hours
Drug: lidocaine 10mg/ml
bolus i.v. + continuous i.v. infusion
Other Name: Lignocaine, Lidocaine

Drug: Metamizole
2,5 g i.v. BD

Drug: Morphine
continuous i.v. infusion adjusted to VAS scale score

Placebo Comparator: Saline infusion
equal volumes of placebo - 0,9% saline i.v.
Drug: Placebo
bolus i.v. + continuous i.v. infusion

Drug: Metamizole
2,5 g i.v. BD

Drug: Morphine
continuous i.v. infusion adjusted to VAS scale score




Primary Outcome Measures :
  1. Opioid consumption in the intraoperative period [ Time Frame: Duration of general anaesthesia ]
    Dose of morphine (or fentanyl changed to the equivalent dose of morphine) administered to patient to achive pain score below 4 points (VAS scale)

  2. Opioid consumption in the postoperative period [ Time Frame: First 24 hours after surgery ]
    Dose of morphine administered to patient to achive pain score below 4 points (VAS scale)

  3. Consumption of the anesthetic agent [ Time Frame: Duration of general anesthesia ]
    The Mean/median vaule of minimal alveolar concentration (MAC) necessary to maintain general anesthesia

  4. Hemodynamic stability [ Time Frame: Duration of general anesthesia ]
    Comparison of systolic and mean blood pressure value to value (5 minutes interval, comparison of exceeding 10% of the previous value, total number of exceedances)

  5. Number of hemodynamic intervations [ Time Frame: Duration of general anesthesia ]
    Total number hemodynamic interventions (total dose of vasoactive medication use according to study protocol)

  6. Intraoperative fulid therapy [ Time Frame: Duration of general anesthesia ]
    Total amount and type of fluids, blood products administered to patient


Secondary Outcome Measures :
  1. The Incidence of postoperative delirium [ Time Frame: First 72 hours (after surgery), once per shift ]
    Patient assessed with the CAM-ICU tool

  2. Indicators of safety [ Time Frame: Intraoperatively and first 24 hours (after surgery) ]
    Incidence of side effects (according to Summary Product Characteristics)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Vascular surgery on aorta or iliac artery
  • Proximal anasthomosis of a by-pass in the abdominal cavity

Exclusion Criteria:

  • Contraindications for administration of lidocaine (according to Summary Product Characteristics)
  • Preoperative administration of any pain relief medication in patient, especially opioides (excluding pre-analgesia)
  • Heart block second or third-degree, previous pacemaker implantation, chronic atrial fibrillation
  • Antiarrhythmic medication on regular basis (excluding b-blockers prescribed due to coronary artery disease)
  • Other health problems: chronic heart failure (ejection fraction LVEF<30%), epilepsy or any episode of seizure, chronic renal failure (AKIN 3-5), chronic liver failure ( class B or C in the Child-Pugh classification), Myasthenia gravis, hypoproteinemia,
  • Cognitive or mental dysfunction, that prevents proper cooperation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691726


Locations
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Poland
Leszek Giec Upper-Silesia Medical Center of the Medical University of Silesia in Katowice
Katowice, Poland, 40-635
Sponsors and Collaborators
Łukasz Krzych
Investigators
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Study Director: Łukasz J Krzych, Professor Medical University of Silesia, Katowice
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Responsible Party: Łukasz Krzych, Professor, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT04691726    
Other Study ID Numbers: GCM
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Łukasz Krzych, Medical University of Silesia:
lidocaine
analgesia
general anesthesia
vascular surgery
aorta
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Pain, Postoperative
Plaque, Atherosclerotic
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Aortic Diseases
Dipyrone
Lidocaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics