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

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Brief Title

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

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

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.
    

Detailed Description

      All enrolled participants will be randomized, using random-number generator, to two groups -
      group A (intervention - perioperative continuous infusion of lidocaine) and group B (without
      intervention - perioperative continuous infusion of placebo). Study is designed as
      double-blinded: neither patients nor perioperative care givers (surgeons, anesthetists,
      nurses) will be aware to which group a patient has been assigned. A coordinator of
      randomization process will be responsible to ask an anesthetist or a nurse (a person not
      taking part in participant's perioperative care) to prepare a set containing respectively: 40
      ml of 1% lidocaine or 40 ml of 0,9% NaCl (placebo) before surgery. Syringes will be labeled
      "Tested Drug". All data regarding patient's assignment to the respective groups will be
      available only to the coordinator of the study.

      Anaesthesia will be performed by anesthetist experienced in vascular surgery. Every patient
      will be premedicated with midazolam (3,75mg-15 mg orally), adjusted to his/her body weight.
      Premedication efficacy will be assessed before induction using RASS scale (Richmond
      Agitation-Sedation Scale).

      During induction of anaesthesia: fentanyl (0,01-0,02 mg / kg i.v.), propofol (1-2 mg/kg
      i.v.), atrakurium (0,5 mg/kg i.v.) will be given. Depth of anaesthesia will be monitored with
      BIS index (bi-spectral index) or entropy till the emergence. Patients scoring above 2 points
      in APFEL scale will receive antiemetic drug - ondansetron 8 mg i.v..

      Intraoperative monitoring will consist of: non-invasive (NIBP) or invasive blood pressure
      monitoring (IBP), anesthetic agent concentration monitoring (MAC, minimal alveolar
      concentration), pulse oximetry (SpO2), capnometry (etCO2) and anesthetic depth monitoring as
      above.

      During co-induction mechanical ventilation will be performed in CMV mode (controlled
      mechanical ventilation). Breathing frequency will be adjusted to etCO2 values. Tidal volume
      will be set on 6-8 ml/ kg IBW (ideal body weight) and positive end-expiratory pressure set on
      5 cm H2O. Fresh gases flow mixture will be adjusted according to SpO2 92-100% values. After
      induction, desflurane will be used in concentrations maintaining depth of anaesthesia between
      40-60 BIS/entropy values. In case of BIS/entropy values out of the range during anesthesia,
      all the events and duration time will be recorded. After general anesthesia mean anesthetic
      concentration will be counted and recorded.

      All participants apart from medication used to perform general anaesthesia will receive 1g of
      paracetamol i.v. before induction as preemptive analgesia and intravenous bolus of the
      "tested drug" in the volume of 0,15 ml/kg IBW given over 1-2 minutes, followed by continuous
      infusion of "tested drug" with ratio of 0,2 ml/kg IBW/h intraoperatively. Postoperatively
      infusion will be continued with ratio 0,1ml/kg IBW/h for the next 24 hours. According to
      patient's assignment syringe " tested drug" will contain 1% lidocaine in group A or normal
      saline in group B.

      Titrated doses of 0,05 mg of fentanyl i.v. will be administered as intraoperative analgesic
      medication. Final dose of fentanyl used during general anaesthesia will be recorded and then
      changed to the equivalent dose of morphine.

      Blood pressure measurements will be taken every 5 minutes to assess hemodynamic stability.
      Initial value of patient's systolic blood pressure (SBP) and mean arterial pressure (MAP) in
      the operating theater will be recorded. SBP within the range from 100 to 160 mmHg and MAP >70
      mmHg will be regarded as a target value (TV). In case of sudden increase in BP or HR within
      TV values associated with painful stimulation from operating field (assessed by experienced
      anesthetist), titrated dose of fentanyl will be given.

      To maintain hemodynamic stability:

        1. In case of decrease in BP or MAP below the TV limit: fluid challenge iv with balanced
           crystalloids will be commenced, especially in case of pulseoximetry or IBP wave
           variation. If the patient is not responding to fluid challenge, ephedrine in titrated
           doses of 5-10 mg will be given intravenously to maximal dose of 25 mg. If still
           ineffective, continues infusion of noradrenaline will be commenced.

        2. In case of increase SBP above the limit: if painful response present, i.v. bolus of
           fentanyl in titrated doses will be given to maximal dose of 0,2 mg to achieve BP
           decrease to the TV. If ineffective, start re-assessment: painful stimulation present -
           FNT iv, no painful stimulation - urapidyl in titrated doses of 5 mg iv administered to
           the effect.

        3. In case of increase in SBP or MAP above the limit associated with the clamping of aorta,
           urapidyl can be given in titrated doses as above.

      Final decision regarding maintenance of hemodynamic stability in association with clinical
      context will be up to the anesthetist.

      The number of hemodynamic interventions, BP values, total time out of the range and
      intraoperative fluid therapy (total amount and type of fluids, blood products), total dose of
      vasoactive medication will be recorded.

      Postoperative care After the surgery, patients will be transferred to post surgical
      high-dependency unit (HDU). Proper analgesic treatment will be continued. Infusion of "tested
      drug" will be stopped 24 hours after the surgery.

      Visual Analog Scale will be used to assess efficiency of analgesic treatment every 4 hours,
      with target value <4 points. Analgesia in postoperative period will consist of: continues
      infusion of opiate (morphine) rate adjusted according to titration method, metamizole 2,5g
      i.v. BD and continues infusion of "tested drug" (1% lidocaine or normal saline according to
      the assignment).

      In case of pain exceeding 4 points in VAS scale, patient will receive bolus of 3 mg of
      morphine i.v., with reassessment after 15 minutes. If no improvement is obtained, second
      bolus of 3 mg of morphine i.v. will be administered followed by increase in the morphine
      infusion rate by 1 mg/h.

      Any side effects in postoperative period especially associated with analgesic medication,
      will be recorded (according to Summary Product Characteristics, 24 hours observation),
      cardiovascular complications (death related to cardiovascular problems, non-fatal acute
      coronary syndrome; 30 days observation), incidence of post-operative delirium (POD,
      assessment with CAM or CAM-ICU scale, Confusion Assessment Method or Confusion Assessment
      Method in Intensive care Unit, 24 hour observation) Statistical analysis Statistical analysis
      will be performed with the use of the StatsDirect 3.1 program. The nature of the variables is
      verified by the Shapiro-Wilk test and the evaluation of quantile-quantile charts.
      Quantitative variables will be presented as arithmetic mean and standard deviation (SD) or
      median and interquartile range (IQR, interquartilerange). Qualitative variables are presented
      in the form of absolute values and percentage. The assessment of differences between the
      groups for quantitative variables will be performed using the Student's t-test with the
      variance assessment or the Mann-Whitney U test. For qualitative variables, contingency tables
      and a chi-square test will be used. The criterion of statistical significance is set at
      p˂0,05.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Opioid consumption in the intraoperative period

Secondary Outcome

 The Incidence of postoperative delirium

Condition

Abdominal Aorta Aneurysm

Intervention

lidocaine 10mg/ml

Study Arms / Comparison Groups

 Lidocaine infusion
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

January 29, 2019

Completion Date

February 2022

Primary Completion Date

January 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Łukasz J Krzych, Professor, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT04691726

Organization ID

GCM


Responsible Party

Sponsor-Investigator

Study Sponsor

Łukasz Krzych


Study Sponsor

Łukasz J Krzych, Professor, Study Director, Medical University of Silesia, Katowice


Verification Date

December 2020