|Year : 2019 | Volume
| Issue : 3 | Page : 752-759
Unilateral paravertebral block guided by nerve stimulator with a single-level injection for ipsilateral hernioplasty using 0.5% levobupivacaine Hcl versus 2% hyperbaric prilocaine Hcl
Ahmed M Abd-El Galeel1, Mohammed A Frahat2
1 Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
2 Department of General Surgery, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
|Date of Submission||09-Nov-2019|
|Date of Decision||09-Nov-2019|
|Date of Acceptance||26-Nov-2019|
|Date of Web Publication||10-Feb-2020|
Ahmed M Abd-El Galeel
Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo
Source of Support: None, Conflict of Interest: None
Background Thoraco-lumbar paravertebral blockade (PVB) provides the best alternative for anesthesia in lower abdominal surgeries owing to minimization of postoperative pain, reduction of nausea and vomiting, shortened hospital stay, patient satisfaction, and rapid return to normal activities.
Aim This study was designed to compare two local anesthetics drugs, levobupivacaine Hcl 0.5% versus hyperbaric prilocaine Hcl 2%, used in PVB-guided nerve stimulator.
Patients and methods A total of 60 American Society of Anesthesiologists I and II patients scheduled for elective unilateral open technique hernioplasty under regional anesthesia using ipsilateral thoraco-lumber PVB technique were divided into two groups. Patients were randomly assigned to receive a single injection of thoraco-lumbar PVB-guided nerve stimulator with local anesthetic 20 ml in total volume, levobupivacaine Hcl 0.5% (group L) (n=30) and hyperbaric prilocaine Hcl 2% (group HP) (n=30), at 12 thoracic vertebra (T12), with a catheter inserted in PV space. Parameters measured were onset and offset time of anesthesia and motor block, hemodynamics evaluation, numeric rating scale for pain assessment, blood glucose level, cortisol level, interleukin 6 level, time of first voiding, patient satisfaction, postoperative complications, and first 24-h postoperative morphine consumption.
Results There was statistically significant longer time of onset of sensory block and motor regression in group L than group HP. Patient stress response was highly significantly lower in each group when compared between values at T0 and T1, whereas the response was significantly lower in HP group only at T1 but insignificantly at T2. Postoperative morphine consumption was significantly higher in group L than group HP only at T0, whereas was insignificant in T1, T2, T3, T4, T5, and T6 postoperatively.
Conclusion PVB is a highly efficient anesthetic technique with lesser complications than general or regional anesthesia.
Keywords: local anesthetic, methemoglobinemia, numeric rating scale, paravertebral block, postanesthetic care unit, transient neurological symptoms
|How to cite this article:|
Abd-El Galeel AM, Frahat MA. Unilateral paravertebral block guided by nerve stimulator with a single-level injection for ipsilateral hernioplasty using 0.5% levobupivacaine Hcl versus 2% hyperbaric prilocaine Hcl. Sci J Al-Azhar Med Fac Girls 2019;3:752-9
|How to cite this URL:|
Abd-El Galeel AM, Frahat MA. Unilateral paravertebral block guided by nerve stimulator with a single-level injection for ipsilateral hernioplasty using 0.5% levobupivacaine Hcl versus 2% hyperbaric prilocaine Hcl. Sci J Al-Azhar Med Fac Girls [serial online] 2019 [cited 2020 Feb 29];3:752-9. Available from: http://www.sjamf.eg.net/text.asp?2019/3/3/752/278058
| Introduction|| |
Peripheral nerve block  as regional anesthesia is frequently used for extremity surgeries to optimize intraoperative and postoperative pain relief . It can provide prolonged sensory block with minimization of postoperative pain, less time for motor blockade with rapid return to normal activities, shortened hospital stay, decrease economic cost, and improved patient satisfaction, which is why long-acting local anesthetics (LAs) have better safety clinical profiles . Owing to its more rapid onset, spinal anesthesia is commonly used for lower abdominal surgeries ; however, spinal anesthesia is not safe for all patients (e.g. in whom hypotension is harmful, such as in patients with ischemic heart disease and those with renal or hepatic diseases). Moreover, there are complications such as postoperative shivering, nausea and vomiting, backache, and urinary retention . The adverse effects of epidural anesthesia are similar to those of spinal anesthesia but are less common and less serious . Bupivacaine, the widely used LA in regional anesthesia, is available in a commercial preparation as a racemic mixture (50 : 50) of its two enantiomers, levobupivacaine S (−) isomer and dextrobupivacaine R (+) isomer . Severe central nervous system and cardiovascular adverse reactions reported after inadvertent intravascular injection or intravenous regional anesthesia have been linked to the R (+) isomer of bupivacaine . The levorotatory isomers were shown to have a safer pharmacological profile with less cardiac and neurotoxic adverse effects; thus, owing to decreased toxicity of the pure S (−) enantiomers of bupivacaine, levobupivacaine and prilocaine were introduced into the clinical anesthesia practice . Paravertebral blockade (PVB) has the potential to offer abdominal wall anesthesia and long-lasting pain relief with minimal adverse effects . PVB involves injection of LAs in space immediately lateral to where the spinal nerves emerge from the intervertebral foramina; the injection can be used either unilaterally or bilaterally . To reduce the risk of specific toxic characteristics reported by bupivacaine-related severe toxicity, nonracemic LAs, such as levobupivacaine and prilocaine, emerged at the right moment, both of which are the pure left isomers of bupivacaine and quite similar in physicochemical properties . Levobupivacaine Hcl 0.5% [the enantiomerically pure (S-enantiomer) amide LA drug) is chemically described as (S)-1-butyl-2-piperidylformo-2, 6-xylidide hydrochloride ,. Hyperbaric prilocaine Hcl 2% is a LA of the basic ester type; it is rapidly absorbed into the blood after parenteral application into the tissue and rapidly degrades to para-aminobenzoic acid −diethylaminoethanol by plasmal esterases (pseudocholinesterase) . Furthermore, the formation of the precursor of the substance P, the pre-protachykinin, can be inhibited by prilocaine . Methemoglobinemia is a condition in which an abnormal proportion of the iron in the heme moiety of hemoglobin is oxidized to the ferric state leading to impaired oxygen transport and ‘anemic hypoxia.’ It occurs when using prilocaine in infants and young children (2–6 years) . The manufacturer of prilocaine and the American Dental Association recommend a maximum allowable dosage of 4% prilocaine plain of 8 mg/kg or 600 mg if more than or equal to 70 kg. American Academy of Pediatric Dentistry endorses a maximum safe dosage of prilocaine (plain or with epinephrine) of 6 mg/kg or 400 mg . Clinical features of methemoglobinemia depend on the methemoglobinemia levels in blood. Cyanosis manifests when the methemoglobinemia levels reach 15–20%. Levels between 20 and 45% are associated with dyspnea, lethargy, and headaches. Methemoglobinemia levels above 45% are usually associated with impaired consciousness, and levels above 55% can cause seizures, coma, and cardiac arrhythmias . Treatment for symptomatic acquired methemoglobinemia includes the administration of a 1% solution of methylene blue at 1–2 mg/kg given intravenously over 5 min; this may be repeated if symptoms do not resolve in 20–30 min . Methylene blue is first reduced by the enzyme nicotinamide adenine dinucleotide phosphate–methemoglobin reductase to leukomethylene blue, which then reduces the methemoglobin to hemoglobin . The sensory block provided by levobupivacaine is similar to that produced by an equivalent dose of prilocaine in extradural and peripheral nerve block .
| Aim|| |
The aim of this study is to compare between injection of LAs levobupivacaine Hcl 0.5% versus hyperbaric prilocaine Hcl 2% in a single-level unilateral PVB-guided nerve stimulator, for ipsilateral inguinal hernia repair. Assessment of sensorial and motor blockade efficacy is the primary outcome, whereas secondary outcomes are to assess hemodynamic changes, patient stress response, postoperative analgesic effect evaluation, time to first spontaneous bladder voiding, patient satisfaction, and postoperative complications of this procedure, including transient neurological symptoms.
| Patients and methods|| |
This prospective, randomized, and double-blind clinical study was approved by the clinical research Ethics Committee of Anesthesia and Intensive Care Department, Faculty of Medicine, Al-Azhar University, Egypt, conducted in the operation theater at Anesthesia and Intensive Care Department, Bab Elshereia University Hospital, Al-Azhar University, Cairo, Egypt. Enrollment study started in August 2015 and ended in September 2017. A total of 60 patients with American Society of Anesthesiologists status I and II, scheduled for elective unilateral open technique hernioplasty under regional anesthesia using ipsilateral thoraco-lumber PVB, aged between 21 and 65 years of age, and BMI less than 35% were recruited. The selected cases were categorized into two groups, with 30 patients each. Patients will be randomly assigned to receive a single-injection thoraco-lumber PVB guided by nerve stimulator with LA 20 ml total volume in each group, levobupivacaine Hcl 0.5% (group L) (n=30) and hyperbaric prilocaine Hcl 2% (group P) (n=30) at (T12) with a catheter inserted in PV space. During the preoperative visit on the day before the operation, the patients were introduced to the concept of the numeric rating scale for pain (NRS), which ranged from 0=no pain to 10=worst pain imaginable , which was used in this study, as the advantages include ease of administration and scoring, multiple response options, and no age-related difficulties. After obtaining informed written consent, randomization was done by computer-generated sealed opaque envelops. The sample size was calculated in each group with α error 0.05 and power 80% for study purpose. The exclusion criteria included a history of hypersensitivity to any of the drugs used in the study; BMI more than 35%; significant cardiac, pulmonary, hepatic, or renal disease; coagulation disorder; lack of patient consent; psychiatric, apprehensive, or uncooperative patients; infection at the site of injection; and severe spine and chest deformity. All patients received infusional fluid therapy consisting of 20 ml/kg of sterile saline solution (NaCl 0.9%) throughout the operation. During the operation and 30 min postoperatively, standard noninvasive monitoring, including electrocardiogram, pulse rate, mean arterial blood pressure measurement, and oxygen saturation by pulse oximetry, was applied for all the patients. All patients were sedated using midazolam in a dose of 0.02 mg/kg intravenous 10 min before the start of PVP.
Technique of paravertebral blockade
Patients were placed in a setting with the feet of the patients relaxed on a stool. The anesthesiologist scrubbed, and the technique was done under complete aseptic condition. Identification of the level of injection was done, where the tip of the scapula is at the level of T7 spinous processes, and then the required thoracic spinous process (T12) was identified, and at 2.5–3 cm lateral to the middle, a point was marked on the middle of the spinous process, which was at level of T12. After aseptic preparation of the skin, a skin weal was raised with a LA solution lidocaine 1% 2 ml at the injection site, and then by using a 22-G spinal needle, the needle was introduced to strike the transverse process of the vertebra below at a depth of ∼3–4.5 cm. When the bone was felt as a measurement of the depth of the transverse process, then the insulated needle was redirected 10–15° cephalic or caudally using nerve stimulated guided insulated needle set (PAJUNK Germany Plexo-Long Nano-Linacc, Meier cannula Facette 19 G×100 mm, lock and connecting cable, injection hose 40 cm long, catheter 20 G×50 cm with central opening, stylet, graduation, adapter for catheter, filter, and fixolong). Single injection was done by 20 ml volume at the level of T12, either in group L (n=30), levobupivacaine Hcl 0.5%, or group P, hyperbaric prilocaine Hcl.
A nerve stimulator was used to identify a muscular response appropriate for the T12 level. A 100 mm 19 G insulated needle (PAJUNK) was introduced perpendicularly to the skin at the point of LA injection using the following nerve stimulator settings: 2 mA, 9 V, and 1 Hz. Initially, contractions of the paraspinal muscles were seen as a result of direct muscle stimulation. After the paravertebral space had been entered, the stimulating needle was gently manipulated into a position to allow an adequate muscular response with a stimulating current of 0.4–0.6 mA. Adequate responses were lower abdominal, inguinal, and cremasteric muscles contraction, and at this point, LAs 20 ml volume of either levobupivacaine Hcl 0.5% or hyperbaric prilocaine Hcl 2% was injected. Radiological studies were done to confirm position of the catheter and distribution of LA in the PVS using ultravist contrast diluted with a sterile water (1 : 1) 20 ml at single level (T12) ([Figure 1]). Baseline heart rate and mean arterial blood pressure (T0) were recorded before local anesthetics injection in all patients included in this study, and at 10 min after PVB (T1), 30 min after PVB (T2), at end of operation (T3), sixth hour postoperatively (T4), and 24 h postoperatively (T5). The efficacy of LAs blockade technique was assessed by onset time of anesthesia and duration of sensorial block. Assessment of motor block was done by Bromage scale, where normal muscular function is grade 1; slight depression in muscular function is grade 2; very week muscular action persisting is grade 3; and complete block, with no movement is grade 4 . Motor block onset time is the time elapsed from injection of the LAs up to complete motor block. NRS in every patient was assessed, at end of operation (T0), sixth hour (T1), 12th hour (T2), 18th hour (T3), and 24 h (T4) postoperatively. Blood samples were drawn from peripheral vein to assess patient stress response through assessment of plasma level of blood glucose randomly (normally 80–110 mg/dl) by colorimetry, cortisol (normally 15–25 µg/dl), and interleukin 6 level (normally 4–11 pg/ml) by electrochemiluminescence. All samples in this study were centrifuged and stored thereafter at ˗20°C until analysis. All blood samples were obtained at baseline (before injection of LAs) (T0), immediately when arrival to postanesthetic care unit (PACU) (T1), and 24 h postoperatively (T2). Postoperative analgesia was accomplished with oral paracetamol 1 g at six hourly intervals. Additionally, in the case of inadequate pain relief (NRS ≥5), a bolus of morphine 0.05 mg/kg intravenously was given. Morphine consumption during the first 24 h postoperatively was recorded at 2, 4, 6, 12, and 24 h postoperatively, and also, total consumption within first day was calculated. Patients who developed postoperative nausea or vomiting received intramuscular injections of 10-mg metoclopramide. Time of first spontaneous voiding (min) was recorded; there was no need for urinary catheter insertion in either group. Any adverse events were assessed, such as failure of anesthetic procedure, hypotension, vascular puncture, dural puncture, pruritus, nausea and vomiting, and transient neurological symptoms such as convulsion, which were noticed and recorded if occurred during the first 24 h postoperatively. Moreover, before patients were discharge home, overall patient satisfaction (range from 1=absolutely satisfied to 10=absolutely not satisfied) was recorded.
Data were collected, tabulated, coded, and then analyzed using SPSS for Windows, Version 15.0. Chicago, SPSS Inc. First, numerical variables were examined for normality and then were presented as mean±SD or median (interquartile range) whenever appropriate. On the contrary, categorical variables were presented as number of cases (percent). Unpaired Student t test was used for between-group comparison of numerical variables if they showed normal distribution, otherwise Mann–Whitney test was used, which was also applied for comparison between maximum sensory blockade levels among the two groups. c2 test or Fisher’s exact test was used, whenever appropriate, for comparison between groups regarding categorical variables, and analyses using one-way analysis of variance followed by Tukey’s (post-hoc) test were done for intergroup comparisons. A difference with P value less than or equal to 0.05 was considered statistically significant, a difference with P value less than or equal to 0.01 was considered moderately significant, and a difference with P value less than or equal to 0.001 was considered highly significant, otherwise it was insignificant.
| Results|| |
There were no significant differences between levobupivacaine (L) group and hyperbaric prilocaine (HP) group regarding demographic data or for duration of operation (P>0.05). Regarding hemodynamics (heart rate and mean arterial blood pressure), there were insignificantly differences for heart rate or mean arterial blood pressure at different times of the study, at baseline (T0), at 10th min (T1), at 30th min after PVB (T2), end of operation (T3), sixth hour (T4), and 24 h postoperatively (T5) (P>0.05). However, regarding onset time of sensory blockade after PVB, it was significantly longer in group L group than HP group (P=0.012), whereas regarding time of regression, the groups were insignificantly correlated (P>0.05). Regarding maximum motor block after 10 min of PVB assessed by Bromage scale (grade 4), the groups were insignificantly correlated (P>0.05), whereas regarding its regression assessed by Bromage scale (grade 1), it was significant longer in L group than HP group (P=0.019). Likewise, regarding patient stress response, represented by blood glucose, cortisol, and interleukin 6 levels, the response was highly significant lower within each group when compared between values at different times of study by post-hoc test for intergroup comparisons at baseline (T0), PACU (T1), and 24 h. postoperatively (T2) (P<0.001), whereas in comparison between two groups of the study for blood glucose, cortisol, and interleukin 6 levels, only at T1, these were significantly lower in HP group than L group (P=0.008, 0.035, and P<0.001, respectively). Regarding NRS as pain assessment, it was higher only at the end of operation (T0) and at second hour postoperatively (T1) in group L than group HP (P=0.034 and =0.040, respectively). However, for morphine consumption in the first 24 h postoperatively, it was significantly higher only at PACU (T0) and at second hour postoperatively (P=0.002, and =0.033, respectively). Regarding time of first spontaneous voiding, it was longer in L group than HP group (min), but the difference was insignificant (P=0.137). Lastly, there were no significant differences regarding degree of patient satisfaction or postoperative complications when compared in both groups (P>0.05) ([Table 1],[Table 2],[Table 3],[Table 4],[Table 5],[Table 6],[Table 7],[Table 8],[Table 9],[Table 10],[Table 11]).
|Table 2 Comparison between two groups according to heart rate (beats/min)|
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|Table 3 Comparison between two groups according to mean arterial pressure (mmHg)|
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|Table 4 Comparison between two groups according to sensorial and motor blockade (onset and regression) (min)|
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|Table 5 Comparison between two groups according to blood glucose level (mg/dl)|
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|Table 6 Comparison between two groups according to cortisol level (µg/dl)|
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|Table 7 Comparison between the two groups of the study as regards interleukin 6 level (pg/ml)|
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|Table 8 Comparison between two groups according to numeric rating scale for pain|
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|Table 9 Comparison between two groups according to postoperative morphine consumption in first 24 h (mg)|
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|Table 10 Degree of patient satisfaction and time of spontaneous bladder voiding (min)|
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|Table 11 Comparison between two groups according to postoperative complications|
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| Discussion|| |
PVB is used as an alternative to spinal and epidural anesthesia, which minimizes the respiratory and cardiovascular effects of central neuraxial block . This technique has the potential to offer unilateral or bilateral abdominal wall anesthesia and long-lasting pain relief with minimal adverse effects , to provide prolonged sensory block with minimization of postoperative pain , to reduce nausea and vomiting, to shortened hospital stay, and to lead to rapid return to normal activities . In this study, insignificant differences were found regarding demographic data (age, height, weight, American Society of Anesthesiologists status Ι/ΙΙ, and sex) and also duration of surgery. Regarding hemodynamic stability (heart rate and mean arterial blood pressure), there were insignificant differences during the different times of recording. These results came in agreement with Casati et al. , in spite of different methodology, who studied interscalene brachial plexus block for shoulder surgery, and compared the effect of amide LA levobupivacaine and prilocaine on hemodynamic parameters.
Regarding the onset time of sensorial blockade, time of blockade duration, and for motor regression, it was found that, in levobupivacaine group, there was significantly delayed onset, same time of blockade duration, and delayed motor regression when compared with prilocaine, which may be owing to nearly 40% of levobupivacaine was presented in suppressing tetrodotoxin-resistant sodium ion channels and also, for the apparent reason that prilocaine concentrations were presented as the hydrochloride salt, rather than as a base, like levobupivacaine, which underestimated the concentration by 13%. The current study was in agreement with the study done by Heid et al. , who studied epidural anesthesia with levobupivacaine versus prilocaine for total knee arthroplasty. Moreover, it was in agreement with the study done by Fournier et al. , who compared levobupivacaine versus prilocaine in sciatic nerve block and found that levobupivacaine provided delayed onset of sensory block and also delayed motor regression after sciatic nerve block using the Labat approach than the same dose of hyperbaric prilocaine in foot and ankle surgery and achieved better control of postoperative pain. This study in agreement with that done by Cline et al. , in spite of different methodology, who studied postoperative analgesia and effectiveness of levobupivacaine compared with prilocaine in patients undergoing an axillary brachial plexus block for minor hand surgeries. However, these results were in disagreement with the study done by Kathirvel et al. , who studied the effects of intrathecal ketamine added to levobupivacaine versus hyperbaric prilocaine for spinal anesthesia in knee arthroscopy; they found that a single dose of intrathecal combination of ketamine with levobupivacaine or prilocaine produced reliable sensory and motor blockade, where prilocaine induced sensory and motor blocks for a longer duration than levobupivacaine. The difference in result might be owing to different methodology, as in the current study, levobupivacaine versus prilocaine without any combination in PVB was used, and also the difference in concentration of LAs used. Regarding patient stress response, which was assayed by blood glucose, cortisol, and interleukin 6 levels, it was significantly lower in each group when compared with values between baseline and immediately after operation (at PACU), but when compared with each other, the response was significantly lower in prilocaine group than levobupivacaine group at PACU and were insignificant at 24 h postoperatively. This might be explained by less stressed neuroendocrine axis with this technique, and the effectiveness of blocking of the somatic nerves together with the sympathetic chain and the rami communicantes when the LA is placed alongside the vertebral column (in the thoraco-lumber paravertebral space). The current study came in agreement with the study done by Richardson et al. , who assessed postthoracotomy pain by evaluating plasma glucose and cortisol levels only, and found significantly higher levels in levobupivacaine group when compared with prilocaine group at the end of operation. Moreover, these results were consistent with those found by O’Riain et al. , in spite of different methodology, who randomized 160 patients into four groups (general anesthesia versus PVB in each one, with levobupivacaine versus prilocaine in each group) for cancer breast surgery and found that blood glucose, cortisol, and interleukin 6 levels at PACU and 2 h postoperative were significantly higher with levobupivacaine than prilocaine group. However, these results came in disagreement with the study done by Alemanno et al. , who studied the effects of single-shot interscalene block on postoperative analgesia in patients undergoing shoulder arthroplasty with tramadol and levobupivacaine or prilocaine, and interleukin 6, blood glucose, and cortisol levels at PACU and 2 h postoperative were highly significantly higher in prilocaine group; this difference in results might be owing to difference in methodology, and also, the current study used LAs without addition of tramadol.
Regarding postoperative morphine consumption on the first day postoperatively, significant difference was found in only the first 2 h postoperatively, being lower in prilocaine group than levobupivacaine group, which considered prilocaine having a more potent analgesic effect, as it was reported that prilocaine had a more selective effect on nociceptive fibers (Aδ and C fibers). This study came in agreement with that done by Taspinar et al. , who studied, in spite of different methodology, where compared in spinal anesthesia low-dose levobupivacaine or prilocaine with fentanyl in ambulatory inguinal herniorrhaphy, postoperatively rescue dose analgesia in first 24 h, patients were allocated to receive 2.5 mg of levobupivacaine versus 1.75 mg of prilocaine, together with 25 μg of fentanyl (LF and PF groups), the sensory block onset time, time to reach the T6 dermatome, time to two-segment regression, and time to first analgesic requirement were significantly shorter in group PF. However, this study was in disagreement with that done by Crews et al. , who studied comparison of the analgesic efficacy of 0.25% levobupivacaine combined with 0.005% morphine, 0.5% prilocaine combined with 0.005% morphine, or 0.005% morphine alone for the management of postoperative pain in patients undergoing major abdominal surgery. The difference might be explained by different methodology, lower concentration of LAs used, and in the current study, there was no opioid combination with levobupivacaine or ropivacaine.Regarding spontaneous bladder voiding, it was found that time was less in prilocaine group than levobupivacaine group, but was insignificant. This study came in agreement with that done by Casati et al. , who compared spinal anesthesia with hyperbaric bupivacaine, hyperbaric prilocaine, or levobupivacaine for inguinal herniorrhaphy and found that time was less regarding spontaneous voiding for hyperbaric prilocaine than levobupivacaine and lastly for hyperbaric bupivacaine.
| Conclusion|| |
PVB is a simple and easy technique, with low incidence of complications, and it suppresses the patient’s neuroendocrinal stress response to surgery. Administration with hyperbaric prilocaine as LA for PVB led to significantly rapidly onset sensory block, earlier motor regression, fewer patients who need postoperative rescue analgesia, and earlier time of spontaneous bladder voiding, when compared with those with levobupivacaine.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11]