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

NCT04691726 | Completed Phase 4

• 1 other identifier: GCM
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aorta Aneurysm; Abdominal Aorta Atheroma; Surgery; Pain, Postoperative

Keywords

lidocaine; analgesia; general anesthesia; vascular surgery; aorta

Outcome Measures

Primary Outcomes (6)

• Opioid consumption in the intraoperative period

  Dose of morphine (or fentanyl changed to the equivalent dose of morphine) administered to patient to achive pain score below 4 points (VAS scale)

  Duration of general anaesthesia

• Opioid consumption in the postoperative period

  Dose of morphine administered to patient to achive pain score below 4 points (VAS scale)

  First 24 hours after surgery

• Consumption of the anesthetic agent

  The Mean/median vaule of minimal alveolar concentration (MAC) necessary to maintain general anesthesia

  Duration of general anesthesia

• Hemodynamic stability

  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)

  Duration of general anesthesia

• Number of hemodynamic intervations

  Total number hemodynamic interventions (total dose of vasoactive medication use according to study protocol)

  Duration of general anesthesia

• Intraoperative fulid therapy

  Total amount and type of fluids, blood products administered to patient

  Duration of general anesthesia

Secondary Outcomes (2)

• The Incidence of postoperative delirium

  First 72 hours (after surgery), once per shift

• Indicators of safety

  Intraoperatively and first 24 hours (after surgery)

Study Arms (2)

Lidocaine infusion

ACTIVE COMPARATOR

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; Drug: Metamizole; Drug: Morphine

Saline infusion

PLACEBO COMPARATOR

equal volumes of placebo - 0,9% saline i.v.

Drug: Placebo; Drug: Metamizole; Drug: Morphine

Interventions

lidocaine 10mg/ml DRUG

bolus i.v. + continuous i.v. infusion

Also known as: Lignocaine, Lidocaine

Lidocaine infusion

Placebo DRUG

bolus i.v. + continuous i.v. infusion

Saline infusion

Metamizole DRUG

2,5 g i.v. BD

Lidocaine infusion; Saline infusion

Morphine DRUG

continuous i.v. infusion adjusted to VAS scale score

Lidocaine infusion; Saline infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Łukasz Krzych: lead

Study Sites (1)

Leszek Giec Upper-Silesia Medical Center of the Medical University of Silesia in Katowice

Katowice, 40-635, Poland

Location

Related Publications (1)

• Gajniak D, Mendrala K, Konig-Widuch G, Parzonka S, Gierek D, Krzych LJ. Effect of lidocaine on intraoperative blood pressure variability in patients undergoing major vascular surgery. BMC Anesthesiol. 2024 May 7;24(1):170. doi: 10.1186/s12871-024-02550-5.

  PMID: 38714924 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Pain, Postoperative; Agnosia

Interventions

Lidocaine; Dipyrone; Morphine

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Łukasz J Krzych, Professor

  Medical University of Silesia, Katowice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 31, 2020
• Study Start: January 29, 2019
• Primary Completion: June 3, 2022
• Study Completion: July 2, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

PL (1)