BJA Advance Access originally published online on August 5, 2006
British Journal of Anaesthesia 2006 97(5):704-709; doi:10.1093/bja/ael222
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Hyperbaric articaine for day-case spinal anaesthesia
1 Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Central Hospital Helsinki, Finland
2 Department of Anaesthesia, Forssa Hospital Forssa, Finland
*Corresponding author: Department of Anaesthesia, Eye Hospital, Helsinki University Central Hospital, Haartmanstreet 4, PO 220, 00029 HUS, Finland. E-mail: helena.kallio{at}hus.fi
Accepted for publication June 2, 2006.
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Abstract |
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Background. Articaine and lidocaine are clinically very similar suggesting that articaine could be suitable for day-case spinal anaesthesia. A dose–response study with articaine in ambulatory spinal anaesthesia was therefore performed.
Methods. In this randomized double-blind study, 90 day-case surgery patients received spinal anaesthesia with 60 mg (A60), 84 mg (A84) or 108 mg (A108) of hyperbaric articaine hydrochloride. Sensory block was tested with pinprick and motor block on a modified Bromage scale. A structured interview was performed on the first and seventh postoperative days.
Results. Sensory block reached the T10 dermatome in a median (range) of 5 (5–10) and was maintained at this level for 70 (35–145), 70 (15–115) and 85 (20–115) min in the A60, A84 and A108 groups, respectively. Six patients in the A108 group, two in the A84 group and one in the A60 group had maximum spread of analgesia to T1 or higher (NS). Patients in the A108 group needed more medication for hypotension (P=0.018), had more often nausea and vomiting (P=0.027), took oral fluids later (P=0.031) and both sensory block recovery [median (range)] [2.5 (2–4.5) h] (P=0.017) and motor block recovery [2 (1.3–4) h] (P=0.009) were delayed. No patients in the A108 group needed opioid intraoperatively while fentanyl was needed in 5 (17%) and 2 (7%) patients in the A60 and A84 groups, respectively. Discharge criteria were attained in approximately 4.5 h after articaine injection (NS) and no drug-related sequelae were observed.
Conclusions. Hyperbaric articaine 60 and 84 mg resulted in spinal anaesthesia allowing surgery of the lower extremities for about 1 h. Recovery was rapid. Use of 108 mg of articaine is not recommended because of frequent extensive cephalad spread of the block, accompanied by arterial hypotension and nausea.
Keywords: anaesthetics local, articaine; anaesthetic techniques, regional, spinal; surgery, ambulatory
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Introduction |
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Articaine, i.e. 4-methyl-3-(2-[propylamino]-propionamido)-2-thiophenecarboxylic acid, methyl ester hydrochloride1 is an amide-type local anaesthetic with a thiophene ring in the molecule. The amide structure is similar to that of other local anaesthetics, but it contains an additional ester group which is quickly hydrolysed by esterases to inactive articainic acid.2 This is related to very low systemic toxicity.3 4 Articaine was first clinically studied for use in dentistry5 and for epidural anaesthesia.6 7 Its fast onset, short duration of action, good periosteal penetration and low degree of toxicity2 has made it one of the most commonly used local anaesthetics in dentistry worldwide.8 In brachial plexus block and epidural block articaine is in many respects similar to lidocaine, but it has slightly faster onset of action, and slightly shorter duration of action.8 Equivalent doses of hyperbaric articaine and hyperbaric lidocaine result in similar short-lasting spinal blocks.9 On the other hand, in comparison with hyperbaric tetracaine10 and hyperbaric or hypobaric bupivacaine11 spinal anaesthesia with hyperbaric articaine has faster onset9–11 and less side-effects.10 None of these studies reported any signs or symptoms reminiscent of transient neurological symptoms (TNSs). To determine the dose appropriate for spinal anaesthesia in day-case surgery we compared three doses of hyperbaric articaine within a dose range found applicable in the previous spinal anaesthesia studies.9–11
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Methods |
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The Ethics committee and Finnish National Agency for Medicines approved the study, and patients gave their written, informed consent. Ninety adult day-case lower extremity surgery patients under 35 kg m–2 BMI and ASA physical status I–III were randomized in blocks of 12 (4 of each group) to receive hyperbaric articaine hydrochloride 60 mg (A60), 84 mg (A84) or 108 mg (A108) intrathecally. A random number generator was used to determine order of study groups. Exclusion criteria were radicular lower backache symptoms during the preceding year and if the duration of the surgery was estimated to be over 1 h.
One consultant anaesthesiologist (E-VTS) prepared articaine 30 mg ml–1 (3%) in glucose 75 mg ml–1 (7.5%) solution by mixing 60, 84 or 108 mg of plain articaine hydrochloride 40 mg ml–1 (4%) (Ultracain® D ohne Adrenalin, Aventis) and glucose 300 mg ml–1 (30%) (Glucosteril® Baxter) in the volume ratio of three parts to one part. Consequently, the volumes were 2, 2.8 and 3.6 ml, respectively, in Groups A60, A84 and A108. Immediately after preparation this anaesthetist injected the local anaesthetic intrathecally, but he did not participate by other means in the medical treatment or study assessments of the patient. The patient, the investigators and the staff were blinded regarding the study group.
Premedication was oral diazepam 5–15 mg given 1 h before anaesthesia. The patients were continuously monitored with ECG and pulse oximetry. Non-invasive arterial blood pressure was recorded every 5 min in the operating room (OR), every 15 min in the postanaesthesia care unit, and at least once in the day-case ward. MAP <65 mm Hg was defined as the acceptable limit of hypotension and heart rate <50 beats min–1 as bradycardia. The patients were given 500 ml of Ringer's solution and fentanyl 1 µg kg–1 i.v. before spinal anaesthesia.
The patient was turned to the lateral decubitus position with the operative leg downwards and a horizontal spine was verified by using a spirit level. The skin at the puncture site was infiltrated with lidocaine 10 mg ml–1 (Lidocain® 10 mg ml–1; Orion Pharma) with a 25-G Microlance® needle (Becton Dickinson, Ireland). The subarachnoid puncture was performed in the midline of L3–L4 interspace with a 27-G pencil point needle (Pencan® B. Braun) through an introducer. With orifice of the needle facing the non-operative site local anaesthetic solution was injected at a speed of 1 ml over 10 s without barbotage or aspiration. The patient was turned supine immediately after the spinal injection and simultaneously the operating table was placed horizontally. All operations were performed with patients in the supine position.
An anaesthesiologist who was blinded as to which dose the patient had received assessed sensory block and motor block at 5, 10, 15, 20, 25, 30, 45, 60, 75 and 90 min after the intrathecal injection, and at 30 min intervals until full recovery. The segmental level of sensory block to pinprick was assessed on both sides, and the caudal limit of sensory block testing was restricted to S2. Motor block of both legs was tested on the Bromage scale as follows: 0=full movement; 1=inability to raise extended leg, can bend knee; 2=inability to bend knee, can flex ankle; and 3=no movement.
The patients were allowed oral fluids in the recovery room and the first oral intake was registered. A ward nurse recorded times of first voluntary voiding and of achieving discharge criteria. The discharge criteria were the following: no breathing difficulties, stability of arterial blood pressure and heart rate, full orientation of the patient in time and place, ability to walking and dress, ability to drink without nausea or vomiting, micturition, and no more than slight pain. In addition, actual time of discharge was recorded. On the first and seventh postoperative day, an anaesthesiologist blinded to the dose of articaine given interviewed the patients by telephone about adverse effects, i.e. pain, nausea, retching, vomiting, headache and backache. Special interest was paid to possible signs and symptoms of TNSs, which were defined as pain in the gluteal region and radiating to both lower extremities that appeared no more than 24 h after complete recovery from spinal anaesthesia.12
Duration of pinprick analgesia at or above the second sacral dermatome (S2) from the time of injection of the local anaesthetic was defined as the primary outcome variable. The sample size calculation was based on detecting at least a 40 min difference between the groups in sensory block recovery. Assuming a power of 80%, a level of significance of 5%, SD of 54 min,9 it was estimated that 90 patients would be required, 30 in each group.
Data on weight, height and BMI are given as mean (SD). Other continuous variables are reported as median (range). Continuous variables were compared using ANOVA for parametric data and the Kruskal–Wallis test if the data were not normally distributed. Categorical variables are expressed as medians (ranges), and the three groups were compared with the Kruskal–Wallis test. Friedman's test was used for repeated measures, e.g. sensory pinprick analgesia or motor block. Binominal data are given as numbers and percentages and were compared using the 
2-test. A P-value <0.05 was considered statistically significant. Statistical analyses were performed with SigmaStat®, version 3.1 (Systat Software GmbH).
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Results |
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Patient and surgical characteristics (Table 1) did not differ between the groups. All spinal injections were performed in the midline except in one of Group A108 patients in whom the lateral approach was needed. An adjacent interspace puncture was needed in one, one and five patients in Groups A60, A84 and A108, respectively. Three patients reported a sensation of paraesthesia during spinal needle insertion, one patient in Group A84 at the calf of the non-operative leg, one patient in Group A108 at ankle of the operative leg and one patient in Group A108 from knee to heel.
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Sensory analgesia to T10 was reached in a median (range) of 5 (5–10) min in all groups and was maintained at this or a higher level for 70 (35–145), 70 (15–115) and 85 (20–115) min in Groups A60, A84 and A108, respectively (Table 2). The maximal sensory block extension (Fig. 1) or its onset time did not differ between the groups (Table 2). Cervical spread of pinprick analgesia occurred in three patients in the A108 group (C3, C3 and C8) and two patients in the A84 group (C7). The distribution of median spread of sensory block and median degree of motor block are shown in Figures 2 and 3.
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All planned surgery was completed under spinal anaesthesia. Patients in the A108 group did not complain of any pain during surgery. In the A60 group five patients received fentanyl 50–95 µg 45–68 min after spinal anaesthetic injection, and in the A84 group two patients received fentanyl 40 and 50 µg at 50 and 71 min, respectively, after spinal anaesthetic injection (Table 2).
In the operating room, patients in the A108 group needed significantly more rescue medication for hypotension (P=0.018), they had significantly more nausea and vomiting (P=0.025), and first oral fluids were obtained voluntarily significantly later (P=0.031) in this group (Table 3). Both sensory block recovery [2.5 (2–4.5) h] (P=0.017) and motor recovery [2 (1.3–4) h] (P=0.009) were significantly delayed in this group (Table 2). In the operating room bradycardia occurred with similar frequency in the three groups, i.e. 27, 33 and 27%, in the A60, A84 and A108 groups, respectively. Clinically significant bradycardia, which needed rescue medication occurred in 30, 33 and 47% patients, respectively, and was not significantly different between the groups. Other untoward intraoperative side-effects are presented in Table 3.
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Nausea or vomiting was graded as follows: 0, no; 1, nausea; 2, retching; 3, vomitingAfter operation, the patients fulfilled the discharge criteria in a median time of approximately 4.5 h after the injection of the local anaesthetic without any significant differences between the groups (Table 2).
Side-effects of spinal anaesthesia reported on days 1 and 7 are reported in Table 4. On the second postoperative day one female knee arthroscopy patient (A108, BMI 31, 32 yr) had backache with unilateral radicular pain symptoms in the non-operated leg. Bilateral radicular pain symptoms (TNSs) did not occur. In the postoperative interviews PONV symptoms occurred in 4 (13%), 8 (27%) and 1 (3%) patients, respectively, in Groups A60, A84 and A108 (P=0.036). The groups did not differ significantly by means of satisfaction of anaesthesia, i.e. 90, 70 and 67% of the patients were very satisfied with the used anaesthesia method in A60, A84 and A108, respectively. In Group A108 33% of patients were only ‘satisfied’ instead of ‘very satisfied’. Two patients in Group A84 were ‘unsatisfied’ because of PDPH.
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One patient needed epidural blood patch |
Discussion |
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In all patients receiving 60, 84 or 108 mg of hyperbaric articaine analgesia to T10 was achieved. Those patients receiving 108 mg of hyperbaric articaine were pain-free throughout the whole operation, while a few patients receiving either 60 or 84 mg needed rescue opioid during the operation. With 108 mg of articaine there was too extensive cephalad spread in several patients and also significantly more haemodynamic instability and nausea and vomiting intraoperatively compared with the other two groups. Recovery of both motor and sensory block was rapid in all three groups, allowing the patients to ambulate in approximately 2 h (median) after the injection of articaine. The lack of any dose–response relationship in this respect may depend on both rapid vascular uptake of articaine and its inactivation in tissues by ester hydrolysis.8
Only three studies have been published on the use of articaine in spinal anaesthesia.9–11
In 1978, Kaukinen and colleagues9 performed a randomized study with 120 elderly male patients scheduled for minor urologic procedures under spinal anaesthesia. The patients received either articaine or lidocaine 1.25 mg kg–1, but the dose was restricted to 100 mg. Their local anaesthetic solution contained either articaine or lidocaine 50 mg ml–1 and glucose 100 mg ml–1. Sensory and motor blocks developed faster with articaine than lidocaine, but there was no difference in duration of sensory block, motor block or side-effects. Tilting of the patients was not allowed in the protocol, resulting in some patients having unnecessarily high spread of sensory block combined with high incidence of hypotension. The incidence of headache did not differ significantly between the groups (18.3% of articaine and 10% of lidocaine patients). The relatively high incidence of headache was probably related to the use of 22-G spinal needles.
In 1977, Hauenschild10 published a retrospective survey of 12 000 anaesthetics given at his institution between 1967 and 1976. Special interest was paid to those 2000 patients who received hyperbaric articaine 80–100 mg intrathecally. Patients, who had received hyperbaric tetracaine 16–20 mg during earlier years, served as historical controls. Patients who received articaine (5–11 min) were ready for surgery sooner than those who reveived tetracaine (10–15 min). If needed, the patients were placed in a 10–15° head-up position, which prevented the local anaesthetic spread to the upper dermatomes (>T12 or T10). Articaine patients had shorter duration of surgical analgesia than tetracaine patients.
Kozlov and colleagues11 reported retrospective data from patients who were anaesthetized for different lower body surgical procedures lasting for 2–4 h. Single shot spinal anaesthesia with hyperbaric articaine, hyperbaric bupivacaine or plain bupivacaine was given to 123 patients, and continuous spinal anaesthesia with hyperbaric articaine to 15 patients. For operations lasting approximately 2 h a mean (SD) dose of 110 (5) mg of hyperbaric articaine (n=39) or 15 mg of hyperbaric bupivacaine (n=32) was used. No difference in the mean duration of analgesia was observed. The mean duration observed for hyperbaric articaine was 124 min, and that for hyperbaric bupivacaine was 120 min. However, onset of both sensory and sympathetic block was faster with articaine. Hypotension occurred more frequently and earlier with articaine than with bupivacaine.
In the previously published studies on articaine in spinal anaesthesia there was no description of any symptoms resembling TNSs.9–11 The pathophysiology of this syndrome is not fully understood, but it seems to be related to the use of lidocaine.12–14 In the present study five patients experienced backache and one patient (BMI 31) unilateral radicular lower extremity pain, which was not classified as TNSs according to the current definition.12
The incidence of posture-dependent PDPH was 3.3% (3 of 90) in this study, which is a little higher than that in a meta-analysis on the use of non-cutting 27-G spinal needles.15 However, only in one patient (1.1%) the headache was severe enough to indicate treatment with an epidural blood patch.
We conclude that with all three doses of hyperbaric articaine sensory block spread rapidly to the T10 dermatomal level, and the median duration of the T10 block was 70, 70 and 85 min, in the A60, A84 and A108 groups, respectively. Motor block resolved in a median time of 2 h (and sensory block in a median time of 2.5 h while voluntary voiding took place approximately 4–4.5 h after injecting the local anaesthetic). The highest dose, 108 mg, is not recommended because it often resulted in too extensive cephalad spread of the spinal block associated with hypotension and nausea and vomiting.
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