EXPERIENCE WITH APPLICATION OF LEVOBUPIVACAINE FOR SPINAL ANESTHESIA IN LOWER LIMB AMPUTATION AMONG ELDERLY PATIENTS WITH PERIPHERAL ARTERY DISEASE AND CRITICAL ISCHEMIA Makarov D.N., Grechenyuk S.I.
Novokuznetsk Research and Practical Center for Medicosocial Expertise and Rehabilitation for Disabled Persons, Novokuznetsk, Russia
Critical lower limb ischemia (CLLI) is a syndrome of decompensation of chronic arterial insufficiency after arterial diseases of lower extremities [1]. Despite the great achievements in the world medicine during the last decades, namely in angiology and vascular surgery, the annual rate of amputations for critical ischemia is 20-25 per 100,000 of population in the European countries [2, 3]. According to some data, the postsurgical mortality in this category of patients is 26 % [2, 4].
Patients with critical ischemia are usually older persons [5] with various concurrent pathologies (cardiovascular, respiratory, renal, endocrine) [6]. Therefore, realization of anesthesiological procedures for this category of patients presents a kind of a problem for anesthesiologist since an extremity amputation is often conducted according to urgent indications, and time for compensation of concurrent pathology is absent. The preference is given to regional neuroaxial techniques of anesthesia. It has such positive moments as fast initiation of anesthesia, adequate analgesia and neurovegatative protection, good muscle relaxation, long term postsurgical analgesia (in case of use of bupivacaine and ropivacaine), and simplicity of realization. At the same time, spinal anesthesia has some negative effects such as hypotonia and bradycardia after symptomatic blockade, neuro- and cardiac toxicity of local anesthetics [7].
Recently, a new modern anesthetic – levobupivacaine (left-handed quartz of bupivacaine) – has appeared in the toolkit of Russian anesthesiologists. The foreign literature has some findings on successful use of levobupivacaine in obstetric-gynecologic [8] and orthopedic practice [9]. In abdominal surgery [10], ophthalmology [11], as well as comparison of effect of levobupivacaine with bupivacaine and ropivacaine [12, 13]. Almost all studies showed that levobupivacaine was as efficient as other local anesthetics, but with lower cardio- and neurotoxicity that the dextrorotatory isomer bupivacaine [14]. In the modern Russian literature, we did not find any data on use of levobupivacaine for lower extremity amputation in older patients with evident concurrent pathology, i.e. patients with critical ischemia of the extremity. Therefore, this problem presents some interest for further research.
Objective – to assess the efficiency and safety of spinal anesthesia with levobupivacaine in lower limb amputation among elderly patients with critical ischemia.
MATERIAL AND METHODS
The study included 25 patients at the age > 65 with critical lower extremity ischemia at the background of atherosclerosis. During the period from July till December 2018, they received the amputation at the level of the leg or the hip in Novokuznetsk Research and Practical Center for Medicosocial Expertise and Rehabilitation for Disabled Persons. There were 22 men and 3 women. The mean age was 67.7 (95 % CI 66.5-68.8).
18 patients (72 %) received the amputation at the level of the leg, 7 (28 %) – at the level of the hip.
Concurrent pathologies were in 100 % of the patients. Among them, 11 (44 %) patients had ischemic heart disease, effort angina. History of infarction was in 6 (24 %) patients. 23 patients (92 %) had hypertonic disease. Atrial fibrillation was diagnosed in 3 (12 %), chronic cardiac insufficiency – in 13 (52 %), previous acute cerebrovascular accident – in 3 (12 %), chronic kidney disease – in 1 (4 %), chronic pulmonary obstructive disease – in 3 (12 %), gastroduodenal ulcer – in 1 (4 %), diabetes mellitus – in 6 (24 %), chronic iron-deficiency anemia – in 6 (24 %).
All patients received sibazone as premedication (10 mg peros in the evening before surgery, and in the morning in the day of surgery 30 minutes before entering the surgery room). The peripheral vein was catheterized in the surgery room. NaCl 0.9 % infusion was initiated. By the moment of subarachnoidal introduction of anesthetic, the volume of infusion was 250-300 ml. The subarachnoidal space was punctured in sitting position with middle approach at the L3-4 level with the needle Quinke 25G. After identification of the needle position in the spinal space, solution of levobupivacaine 0.5 % (2.5ml or 12.5 mg) was introduced in subarachnoidal manner in free flow of cerebrospinal fluid. Then at the same level, the epidural space was catheterized with the epidural catheter 20G with the needle Tuohy 18G for continuous postsurgical analgesia. Then the patient was placed in supine position.
The time of appearance of sensory blockade was registered (for estimation of achievement of anesthesia, the time of development of sensory block was defined up to the level Th10), maximal level of distribution of sensory blockade, time of regression of sensory blockade up to L1 level, duration of analgesia, a degree of motor blockade according to Bromage modified scale, time of development of motor blockade according to Bromage 3, time of regression of motor blockade up to 0 according to Bromage. The mean arterial pressure (MAP) and heart rate (HR) were registered at basic level and in the minutes 5, 10, 20, 30, 60, 120 and 180 from the moment of anesthetic introduction. The decrease in MAP below 70 mm Hg was defined as hypotension, which was corrected with infusion of vasopressor (noradrenaline). The decrease in HR below 50 per minute was defined as bradycardia, and the patients received intravenous atropine (0.5 mg).
The statistical results were presented as the mean (M) and standard error in the mean arithmetic (m). Shapiro-Wilk’s test was used for making the decision on a type of distribution. Student’s test was used for estimation of differences between the values in normal distribution of the sign, Mann-Whitney U-test – for distribution different from the normal one. The null hypothesis was rejected at p level < 0.05.
Statistica software (version 10.0.1011.0, Statsoft, Inc., USA) was used for statistical analysis of the data.
The study corresponded to Helsinki Declare – Ethical Principles for Medical Research with Human Subject, and the Rules for Clinical Practice confirmed by the Order of Health Ministry of RF, 19 June 2003, No.266. The informed consent for analysis of the personal data was received for all patients (the session protocol of the ethical committee No.4, 25 February 2019).
RESULTS AND DISCUSSION
In this study, the spinal anesthesia with levobupivacaine was conducted for the patients at the age ≥ 65, with lower extremity amputation after critical ischemia. The older patients with atherosclerosis and limb critical ischemia usually show the quite evident concurrent pathology since atherosclerosis has the systemic pattern of lesion, and the pathological process includes almost all vital organs and systems, resulting in influence on treatment outcomes [6]. Therefore, the anesthetic for spinal anesthesia has to provide both efficiency of analgesia and stability of hemodynamics.
In our patients, all 25 patients had efficient anesthesia, i.e. the level of sensory blockade, and a degree of motor blockade were sufficient for realization of lower extremity amputation. The mean maximal height of distribution of sensory blockade was Th8, with low variability of blockade distribution (Th10-Th6). Therefore, the above-mentioned dose of levobupivacaine causes quite predictable level of distribution of sensory blockade that is confirmed by some foreign authors [13]. However some literature data shows that levobupivacaine can cause the quite variable distribution of blockade which is sometimes insufficient for lower extremity surgery [15].
The time of achievement of anesthesia up to Th10 was 12.44 ± 0.29 minutes, time of motor blockade development – up to 3 according to Bromage 13.36 ± 0.35 minutes. It is quite comparable with racemic bupivacaine and ropivacaine [12, 13, 16]. We do not compare lidocaine since a lot of anesthesiologists refuse from it in favor of modern and safer anesthetics due to such side-effects of lidocaine as transitory root excitation, transitory pain in the lumbar region, transitory neurological toxicity [17].
The time of regression of sensory blockade up to L1 level was 266.8 ± 7.48 minutes. Anesthesia after spinal analgesia with 0.5 % levobupivacaine lasted for 343 ± 8.2 minutes (the maximal time – 460 minutes). Therefore, levobupivacaine is not inferior to bupivacaine and is more efficient than ropivacaine in this regard [18]. It was noted that duration of analgesia was correlated with anesthesia level: the higher was duration of analgesia, the longer was analgesia.
The time of regression of motor blockade up to 0 according to Bromage was 282 ± 5.29 minutes, i.e. the patient was completely mobile in the bed, with persistent anesthesia. The possibility of earlier activation is very efficient for older patients since it decreases the risk of venous thrombosis, bedsores and cardiovascular complications.
We were interested with the influence of levobupivacaine on arterial pressure and cardiac rate. The population of patients who receive the lower extremity amputations is presented by patients with evident concurrent pathology, and with non-stable hemodynamics, which increases the risk of cardiovascular complications in the postsurgical period, resulting in hospital mortality increase [19].
The time course of changes in mean arterial pressure (MAP) is presented in the figure 1. A reliable decrease in MAP in relation to the basic level (p < 0.005) was noted in the 5th minute. At all stages of the follow-up, MAP was reliably lower than the basic level (p < 0.005). The maximal decrease in MAP by 19 % (p < 0.005) was noted in the 20th minute, with further trend to increase. However almost all patients demonstrated the arterial pressure within the limits of normal values during the whole period of the follow-up. Two patients (8 %) received the infusion of vasopressors (noradrenaline 0.04 mcg/kg/min.) for correction of hypotonia.
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Figure 1 Time course of changes in mean arterial pressure. |
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The literature includes some findings that levobupivacaine makes a significant influence on arterial pressure and causes the hypotension which requires for vasopressors [15]. Possibly, the stability of hemodynamics was influenced by lower doses of levobupivacaine in our study.
The time course of changes in heart rate is presented in the figure 2. The maximal decrease in HR was noted in the minute 10 – 6 % from the basic value (p > 0.005). However mean HR did not differ at all stages of the follow-up (p > 0.005). However two patients (8 %) required for atropine for correction of bradycardia.
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Figure 2 Time course of changes in cardiac rate. |
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There were not any complications relating to anesthesia.
CONCLUSION
Levobupivacaine 0.5 % is quite efficient and safe anesthetic and can be recommended for spinal anesthesia in lower extremity amputation in older patients with critical ischemia.
Information on financing and conflicts of interests
The study was conducted without sponsorship. The authors declare the absence of any clear or potential conflicts of interests relating to publication of this article.