NCT04691726

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

Completed Phase 4 Last updated 21 December 2022

What this trial tests

Phase 4 trial testing lidocaine 10mg/ml in Abdominal Aorta Aneurysm in 87 participants. Completed in 2 July 2022.

Timeline

29 January 2019

Primary endpoint
3 June 2022

2 July 2022

Quick facts

Lead sponsor	Łukasz Krzych
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	87
Start date	29 January 2019
Primary completion	3 June 2022
Estimated completion	2 July 2022
Sites	1 location across Poland

Drugs / interventions tested

• lidocaine 10mg/ml — full drug profile →
• Placebo
• Metamizole (METAMIZOLE) — full drug profile →
• Morphine

Conditions studied

• Abdominal Aorta Aneurysm — all drugs for Abdominal Aorta Aneurysm →
• Abdominal Aorta Atheroma — all drugs for Abdominal Aorta Atheroma →
• Surgery — all drugs for Surgery →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Łukasz Krzych — full company profile →

Who can join

18 and older, any sex, with Abdominal Aorta Aneurysm or Abdominal Aorta Atheroma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Lidocaine Infusion in High-Risk Vascular Surgery-A Randomized, Double-Blind, Placebo-Controlled Single-Center Clinical Trial.
   Gajniak D, Mendrala K, Cyzowski T, Polak M, et al · · 2023 · cited 4× · PMID 36983312 · DOI 10.3390/jcm12062312
2. Effect of lidocaine on intraoperative blood pressure variability in patients undergoing major vascular surgery.
   Gajniak D, Mendrala K, König-Widuch G, Parzonka S, et al · · 2024 · cited 3× · PMID 38714924 · DOI 10.1186/s12871-024-02550-5