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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
Sponsor study identifier
interventional
87
1 country
1
Study Start
January 29, 2019
Actual (reported)Primary Completion
June 3, 2022
Actual (reported)Study Completion
July 2, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2019
Actual (reported)December 21, 2020
Actual (reported)December 31, 2020
Actual (reported)June 3, 2022
Actual (reported)July 2, 2022
Actual (reported)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
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
equal volumes of placebo - 0,9% saline i.v.
bolus i.v. + continuous i.v. infusion
Leszek Giec Upper-Silesia Medical Center of the Medical University of Silesia in Katowice
Katowice, 40-635, Poland
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.
Łukasz J Krzych, Professor
Medical University of Silesia, Katowice
87 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2020
First Posted
December 31, 2020
Study Start
January 29, 2019
Actual (reported)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
The Incidence of postoperative delirium
First 72 hours (after surgery), once per shift
Indicators of safety
Intraoperatively and first 24 hours (after surgery)
2,5 g i.v. BD
Contact the study team to confirm eligibility.
Primary Completion
June 3, 2022
Actual (reported)Study Completion
July 2, 2022
Actual (reported)Last Updated
December 21, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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