Overview
Impact of Intra- and Postoperative Continuous Infusion of Lidocaine on Analgesia in Vascular Anaesthesia
Status:
Suspended
Suspended
Trial end date:
2022-02-01
2022-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ćukasz KrzychTreatments:
Dipyrone
Lidocaine
Morphine
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.