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Anesth Analg 2004;98:64-67 © 2004 International Anesthesia Research Society
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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In this clinical trial we evaluated the clinical effects of levobupivacaine in spinal anesthesia in children. An open, noncomparative study was performed on 40 children, aged 1–14 yr, undergoing elective lower abdominal or lower limb surgery. A plain solution of S(-)-bupivacaine 5 mg/mL at a mean dose of 0.3 mg/kg body weight (range, 0.2–0.5 mg/kg body weight) was administered via the L3-4 or L4-5 interspace with the patient in the lateral decubitus position. After injection, the patients were placed supine. The spread and duration of sensory analgesia and the degree of motor block were recorded. Satisfactory surgical anesthesia was achieved in 39 of the 40 children. One child received supplemental anesthesia. The mean highest level of sensory block was T4 (range, T2 to L1), and the mean time to the regression of sensory block to T10 was 90 min (range, 43–185 min). A complete motor block was achieved in 36 children. These results are similar to those obtained with racemic bupivacaine in subarachnoid anesthesia in children.
IMPLICATIONS: This noncomparative, descriptive study showed that levobupivacaine, the S(-)-enantiomer of bupivacaine, has equivalent clinical efficacy in spinal anesthesia in children to that of racemic bupivacaine.
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Spinal anesthesia produces a profound and uniformly distributed sensory block with rapid onset and good muscle relaxation, and it results in more complete control of cardiovascular and stress responses than epidural or opioid anesthesia (1). Because of these benefits, spinal anesthesia has gained acceptance for children undergoing surgery in the lower part of the body (2,3).
Bupivacaine is the most common local anesthetic for spinal anesthesia in children (3). Levobupivacaine, the S(-)-enantiomer of bupivacaine, has less potential for cardiovascular and central nervous system toxicity than bupivacaine (4). Levobupivacaine has been used for spinal anesthesia in adults, and its clinical efficacy has been equivalent to that of racemic bupivacaine (5–7). In children, levobupivacaine has been used for caudal anesthesia (8) and ilioinguinal-iliohypogastric nerve block (9), but there are no reports of using levobupivacaine for spinal anesthesia in children.
The aim of this open, noncomparative, prospective clinical trial was to evaluate the clinical efficacy of isobaric spinal levobupivacaine 5 mg/mL in children. The test variables were quality and spread of analgesia and anesthesia, regression of sensory block, perioperative adverse effects, and the time required to reach discharge criteria.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Forty healthy children aged 11 mo to 14 yr, scheduled for surgery below the umbilicus with spinal anesthesia, were enrolled. All the children were included unless they had any contraindications for spinal puncture or levobupivacaine. The study was approved by our ethics committee, it was conducted in accordance with the latest revision of the Declaration of Helsinki (10), and the National Agency for Medicines was notified of the trial protocol. Parents, and children old enough to understand, gave written, informed consent.
All children were premedicated with buccal midazolam and ketamine. For intraoperative sedation, IV thiopental was given in small incremental doses. All children were closely monitored by an anesthesiologist and an anesthetic nurse.
Lumbar puncture was performed with the patient in the lateral decubitus position in the midline with a 27-gauge, 75-mm-long, cutting-point needle. Correct placement of the needle was verified by free aspiration of cerebrospinal fluid (CSF). Plain, isobaric levobupivacaine (Chirocaine®; Abbott Scandinavia AB, Solna, Sweden) was administered intrathecally at a dose of 0.25 mg/kg in children with body weight >40 kg, 0.3 mg/kg in children 16–40 kg, and 0.4 mg/kg in children 
15 kg. After injection of the local anesthetic over 10 s, free aspiration of CSF was again verified.
An electric stimulator (Microstim Plus®; Neuro Technology, Houston, TX) was used to evaluate the width of the analgesic area at 10, 20, and 30 min (3,11). Motor block was assessed with a Bromage scale (12). The time to incision was 10 min, and if there were any signs of inadequate spread or duration of spinal anesthesia, fentanyl 1 µg/kg IV was given for supplementary analgesia.
After surgery, all children received ketoprofen 1 mg/kg IV and acetaminophen 40 mg/kg rectally to prevent postoperative pain, and they were transferred to the postanesthesia care unit (PACU) for continuous monitoring of vital signs and regression of block. The time for regression of sensory block by 2 segments—to T7 (xiphoid process) and to T10 (umbilicus)—was tested every 5 min from 30 min after injection. Bradycardia and hypotension were defined if a value was 
20% of the baseline. If the child was in pain, fentanyl 1 µg/kg or oxycodone 0.05 mg/kg IV was given and the time was recorded.
Children were discharged when they were awake, able to walk unaided, had stable vital signs for at least 1 h, had no or mild pain, had no nausea/retching or vomiting, and were able to tolerate clear fluids. The time to discharge was calculated from the time of the lumbar puncture to the discharge from the hospital.
The follow-up of the children at home was recorded in a diary, which was to be returned a week after surgery. Nonresponders were contacted by telephone.
No statistical analyses were performed because in this pilot trial we did not have a control group. Therefore, descriptive results are presented as mean (SD) and range or number (percentage) of cases, as appropriate. A sample size of 40 children was considered sufficient to provide necessary background information on the performance of intrathecal levobupivacaine.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The demographic data of the children and characteristics of spinal puncture are shown in Table 1. Orthopedic surgery (n = 14), herniotomy (n = 11), and urological surgery (n = 7) were the most common procedures performed.
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The spinal anesthesia was successful in 39 of 40 children. One 13-yr-old girl undergoing patelloplasty was given general anesthesia because of insufficient sensory and motor block. During the lumbar puncture, CSF aspiration had been difficult. In a 14-yr-old boy undergoing ligamentoplasty of the knee, the duration of surgery outlasted the 65-min duration of sensory block, and he was given general anesthesia to complete the surgery. A 5-yr-old boy undergoing herniotomy required supplemental analgesia during skin incision at 10 min after levobupivacaine injection, but thereafter the block performed sufficiently; his Bromage score was 1. In the other 37 children, adequate sensory block was accompanied by complete motor block. The characteristics of sensory block are presented in Table 2.
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There were no intraoperative adverse events. Five children experienced shivering in the PACU: three children vomited once, and one child vomited twice. Eighteen children were pain free in the PACU, but most children (55%) undergoing orthopedic surgery and both children undergoing circumcision and orchidopexy required opioids for rescue analgesia.
Parents of 32 children returned the follow-up diary, and 8 parents gave the information by phone. Seven children developed headache after discharge, two of which were position-dependent and were therefore classified as postdural puncture headache. No epidural blood patches were required.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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This study demonstrates that levobupivacaine is an effective local anesthetic for spinal applications in children. With levobupivacaine, the sensory block characteristics seem to be similar to those obtained with racemic bupivacaine (3,11,13). In trials in which plain and hyperbaric bupivacaine at doses of 0.25 to 0.5 mg/kg have been used for spinal anesthesia in children, the peak height of sensory block ranged from T1 to T12 (mean, T4.5), which is similar to the range of T2 to L1 (mean, T4.5) in this trial. With racemic, isobaric bupivacaine, the regression of sensory block by 2 segments occurs after 78 minutes, compared with 77 minutes obtained with levobupivacaine, to T7 after 89 compared with 84 minutes with levobupivacaine, and to T10 after 103 compared with 90 minutes with levobupivacaine. The time to the first request for rescue analgesia seems to be similar (120 minutes) after surgery with spinal anesthesia with racemic bupivacaine and levobupivacaine.
Levobupivacaine has been investigated in spinal anesthesia in adults. Burke et al. (5) and Glaser et al. (6) have reported that in adults, levobupivacaine at a dose of 0.14–0.28 mg/kg results in a similar distribution of sensory block (T4 to L3) as we found in children. However, the duration of spinal anesthesia in adults seems to be significantly longer than in children because the duration of the sensory block at T10 in adults is 152 minutes, compared with 90 minutes in children (6).
Levobupivacaine has very similar pharmacokinetic properties to those of racemic bupivacaine, but the potential for toxicity with levobupivacaine is less than with racemic bupivacaine (14). Because of decreased cardiovascular and central nervous system toxicity, levobupivacaine is considered to be a safer alternative to racemic bupivacaine in blocks in which large doses of local anesthetics are required. In spinal anesthesia, an effective block is achieved with small-dose regimens, and the potential for systemic toxicity is considered small. However, in intrathecal anesthesia, the drug is given close to the spinal nerves and spinal cord, and, therefore, it is worth considering using a drug with the least potential for toxicity.
In this study, the success rate of spinal anesthesia was high, and the only failure was associated with a difficult aspiration of CSF. This failure was a result of an inadequate puncture technique rather than a consequence of the local anesthetic used. No intraoperative adverse events were observed, and adverse effects in the PACU were relatively few. In the PACU, 13% of the children developed shivering. Shivering seems to be a common complaint in children during sensory block regression, because 10% of children may develop it after spinal anesthesia (3). Thus, spinal anesthesia with levobupivacaine seems to be effective and relatively safe for young children.
In conclusion, this pivotal trial indicates that the clinical characteristics of intrathecal levobupivacaine in young children are fairly similar to those obtained with racemic bupivacaine at the same dose. However, further comparative studies should be performed in the future to determine whether levobupivacaine spinal anesthesia has any advantages over bupivacaine spinal anesthesia in children.
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References |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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- Wolf AR, Doyle E, Thomas E. Modifying infant stress responses to major surgery: spinal vs extradural vs opioid analgesia. Paediatr Anaesth 1998; 8: 305–11.[Web of Science][Medline]
- Bang-Vojdanovski B. 10 Jahre Spinalanästhesie bei Säugligen und Kindern inder orthopädischen Chirurgie: ein klinischer Erfahrungsbericht. Anaesthesist 1996; 45: 271–7.[Web of Science][Medline]
- Kokki H. Spinal anaesthesia in infants and children. Baillieres Clin Anaesthesiol 2000; 14: 687–707.
- Åberg G. Toxicological and local anaesthetic effects of optically active isomers of two local anaesthetic compounds. Acta Pharmacol Toxicol 1972; 31: 273–86.[Medline]
- Burke D Kennedy S Bannister J. Spinal anesthesia with 0.5% S(-)-bupivacaine for elective lower limb surgery. Reg Anesth Pain Med 1999; 24: 519–23.[Web of Science][Medline]
- Glaser C, Marhofer P, Zimpfer G, et al. Levobupivacaine versus racemic bupivacaine for spinal anesthesia. Anesth Analg 2002; 94: 194–8.
[Abstract/Free Full Text] - Alley EA, Kopacz DJ, McDonald SB, Liu SS. Hyperbaric spinal levobupivacaine: a comparison to racemic bupivacaine in volunteers. Anesth Analg 2002; 94: 188–93.
[Abstract/Free Full Text] - Ivani G, DeNegri P, Conio A, et al. Comparison of racemic bupivacaine, ropivacaine, and levo-bupivacaine for pediatric caudal anesthesia: effects on postoperative analgesia and motor block. Reg Anesth Pain Med 2002; 27: 157–61.[Web of Science][Medline]
- Gunter JB, Gregg T, Varughese AM, et al. Levobupivacaine for ilioinguinal/iliohypogastric nerve block in children. Anesth Analg 1999; 89: 647–9.
[Free Full Text] - World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. 52nd World Medical Association, General Assembly, Edinburgh, Scotland, October 2000. Accessed at www.wma.net/e/policy/b3.htm.
- Kokki H, Tuovinen K, Hendolin H. Spinal anaesthesia for paediatric day-case surgery: a double-blind, randomised, parallel group, prospective comparison of isobaric and hyperbaric bupivacaine. Br J Anaesth 1998; 81: 502–6.
[Abstract/Free Full Text] - Bromage PR. A comparison of the hydrochloride and carbon dioxide salts of lidocaine and prilocaine in epidural analgesia. Acta Anaesthesiol Scand 1965; 16: 55–69.
- Kokki H Hendolin H. No difference between bupivacaine in 0.9% and 8% glucose for spinal anaesthesia in small children. Acta Anaesthesiol Scand 2000; 44: 548–51.[Medline]
- Foster RH, Markham A. Levobupivacaine: a review of its pharmacology and use as a local anaesthetic. Drugs 2000; 59: 551–9.[Web of Science][Medline]
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