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01.05.2008 | Originalien

Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery

A multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine

verfasst von: Prof. Dr. T. Koch, A. Fichtner, U. Schwemmer, T. Standl, T. Volk, K. Engelhard, M.F. Stevens, C. Putzke, J. Scholz, M. Zenz, J. Motsch, V. Hempel, A. Heinrichs, B. Zwissler

Erschienen in: Die Anaesthesiologie | Ausgabe 5/2008

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Abstract

Background and objectives

The aim of this randomized, single blind phase IIIb study was to evaluate the efficacy of 0.5% levobupivacaine versus 0.5% bupivacaine and 0.75% ropivacaine administered as epidural anesthesia and 0.125% levobupivacaine versus 0.125% bupivacaine and 0.2% ropivacaine for postoperative analgesia. The study was designed to test the equivalence of the overall profile of levobupivacaine against bupivacaine and ropivacaine. In addition, parameters of clinical safety were assessed.

Methods

A total of 88 patients undergoing hip surgery at 12 German academic hospitals were randomly assigned to 3 different treatment groups. Criteria for drug evaluation were the required epidural volume and time until onset and offset of sensory and motor block, the quality of postoperative analgesia using a pain visual analogue scale and verbal rating scale, as well as the need for rescue medication based on statistical non-inferiority testing.

Results

With respect to onset and offset of sensory and motor blockade, 0.5% levobupivacaine, 0.5% bupivacaine and 0.75% ropivacaine showed clinically significant equivalent profiles for all primary study endpoints. However, the levobupivacaine group showed a higher demand for intraoperative anesthesia. Postoperative analgesia request and pain scales did not differ significantly between groups, but comparatively lower total drug volumes were required in the bupivacaine group. No relevant differences between the trial groups concerning safety parameters were observed.

Conclusions

The efficacy of epidural levobupivacaine for hip surgery and postoperative analgesia is equivalent and shows a comparable clinical profile to bupivacaine and 50–60% higher concentrated ropivacaine. The results of this equivalence study confirm suggestions derived from previous comparative studies.

Lee EJD, Williams KM (1990) Chirality. Clinical pharmacokinetic and pharmacodynamic considerations. Clin Pharmacokinet 18: 339–345PubMedCrossRef

Sidebotham DA, Schug SA (1997) Stereochemistry in anaesthesia. Clin Exp Pharmacol Physiol 24: 126–130PubMedCrossRef

Thomas JM, Schug SA (1999) Recent advances in the pharmacokinetics of local anaesthetics. Long-acting amide enantiomers and continuous infusions. Clin Pharmacokinet 36(1): 67–83PubMedCrossRef

Luduena FP (1969) Duration of local anaesthesia. Ann Rev Pharmacol 9: 503–520PubMedCrossRef

Burm AGL, Meer AD van der, Kleef JW van et al. (1994) Pharmacokinetics of the enantiomers of bupivacaine following intravenous administration of the racemate. Br J Clin Pharmacol 38: 125–129PubMed

Vanhoutte F, Vereecke J, Verbeke N, Carmeliet E (1991) Stereoselective effects of the enantiomers of bupivacaine on the electrophysiological properties of the guinea-pig papillary muscle. Br J Pharmacol 103: 1275–1281PubMed

Kleef JW van, Veering VT, Burm AGL (1994) Spinal anaesthesia with ropivacaine: a double-blind study on the efficacy and safety of 0.5% and 0.75% solutions on patients undergoing minor lower limb surgery. Anesth Analg 78: 1125–1130PubMed

Huang YF, Pryor ME, Mather LE, Veering BT (1998) Cardiovascular and central nervous system effects of intravenous levobupivacaine and bupivacaine in sheep. Anesth Analg 86: 797–804PubMedCrossRef

Graf BM, Martin E, Bosnajak ZJ et al. (1997) Stereospecific effect of bupivacaine isomers on atrioventricular conduction in the isolated perfused guinea pig heart. Anesthesiology 86: 410–419PubMedCrossRef

10.

Bardsley H, Gristwood R, Baker H et al. (1998) A comparison of the cardiovascular effects of levobupivacaine and rac-bupivacaine following intravenous administration to healthy volunteers. Br J Clin Pharmacol 46: 245–249PubMedCrossRef

11.

Valenzuela C, Snyders DJ, Bennett PB et al. (1995) Stereoselective block of cardiac sodium channels by bupivacaine in guinea pig ventricular myocytes. Circulation 92: 3014–3024PubMed

12.

Gherardini G, Samuelson U, Jernbeck J et al. (1995) Comparison of vascular effects of ropivacaine and lidocaine on isolated rings of human arteries. Acta Anaesthesiol Scand 39: 765–768PubMedCrossRef

13.

Cox CR, Faccenda KA, Gilhooly C et al. (1998) Extradural S(-)-bupivacaine: comparison with racemic RS-bupivacaine. Br J Anaesth 80: 289–293PubMed

14.

Bader AM, Tsen LC, Camann WR et al. (1999) Clinical effects and maternal and fetal plasma concentrations of 0.5% epidural levobupivacaine versus bupivacaine for cesarean delivery. Anesthesiology 90: 1596–1601PubMedCrossRef

15.

Lyons G, Columb M, Wilson RC, Johnson RV (1998) Epidural pain relief in labour: potencies of levobupivacaine and racemic bupivacaine. Br J Anaesth 81: 899–901PubMed

16.

Kopacz DJ, Allen HW, Thompson GE (2000) A comparison of epidural levobupivacaine 0.75% with racemic bupivacaine for lower abdominal surgery. Anesth Analg 90: 642–648PubMedCrossRef

17.

Bay-Nielsen M, Klarskov B, Bech K et al. (1999) Levobupivacaine vs bupivacaine as infiltration anaesthesia in inguinal herniorrhaphy. Br J Anaesth 82: 280–282PubMed

18.

Gunter JB, Gregg T, Varughese AM et al. (1999) Levobupivacaine for ilioinguinal/iliohypogastric nerve block in children. Anesth Analg 89: 647–649PubMedCrossRef

19.

Cox CR, Checketts MR, Mackenzie N et al. (1998) Comparison of S(-) bupivacaine with racemic (RS)-bupivacaine in supraclavicular brachial plexus block. Br J Anaesth 80: 594–598PubMed

20.

McLure HA, Rubin AP (1998) Comparison of 0.75% levobupivacaine with 0.75% racemic bupivacaine for peribulbar anaesthesia. Anaesthesia 53: 1160–1164PubMedCrossRef

21.

O’Sullivan EP (1999) Comparison of 0.75% levobupivacaine with 0.75% racemic bupivacaine for peribulbar anaesthesia. Anaesthesia 54: 610

22.

Stewart J, Kellett N, Castro D (2003) The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers. Anesth Analg 97: 412–416PubMedCrossRef

23.

Polley LS, Columb MO, Naughton NN et al. (1999) Relative analgesic potencies of ropivacaine and bupivacaine for epidural analgesia in labor. Anesthesiology 90: 944–950PubMedCrossRef

24.

Capogna G, Celleno D, Fusco Pet al. (1999) Relative potencies of bupivacaine and ropivacaine for analgesia in labour. Br J Anaesth 82(3): 371–373PubMed

25.

Wellek S. (1994) Statistische Methoden zum Nachweis von Äquivalenz. Gustav Fischer, Stuttgart Jena New York

26.

Bromage PR, Burfoot MF, Crowell DE, Pettigrew RT (1964) Quality of epidural blockade. I. Influence of physical factors. Br J Anaesth 36: 342–352PubMedCrossRef

27.

Foster RH, Markham A (2000) Levobupivacaine. A review of its pharmacology and use as a local anaesthetic. Drugs 59(3): 551–579PubMedCrossRef

28.

Glaser C, Marhofer P, Zimpfer G et al. (2002) Levobupivacaine versus racemic bupivacaine for spinal anesthesia. Anesth Analg 94: 194–198PubMedCrossRef

29.

Casati A, Battista B, Fanelli G et al. (2002) A double-blinded, randomized comparison of either 0.5% levobupivacaine or 0.5% ropivacaine for sciatic nerve block. Anesth Analg 94: 987–990PubMedCrossRef

30.

Casati A, Santorsola R, Aldegheri G et al. (2003) Intraoperative epidural anesthesia and postoperative analgesia with levobupivacaine for major orthopedic surgery: a double-blind, randomized comparison of racemic bupivacaine and ropivacaine. J Clin Anesth 15: 126–131PubMedCrossRef

31.

McClellan KJ, Faulds D (2000) Ropivacaine: an update of its use in regional anaesthesia. Drugs 60: 1065–1093PubMedCrossRef

32.

McDonald SB, Liu SS, Kopacz DJ, Stephenson CA (1999) Hyperbaric spinal ropivacaine. A comparison to bupivacaine in volunteers. Anesthesiology 90: 971–977PubMedCrossRef

33.

Gautier P, Kock M de, Huberty L et al. (2003) Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth 91(5): 684–689PubMedCrossRef

34.

Aberg G (1972) Toxicological and local anaesthetic effects of optically acitive isomers of two local anaesthetic compounds. Acta Pharmacol Toxicol 31: 273–286CrossRef

Titel: Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery
A multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine
verfasst von: Prof. Dr. T. Koch
A. Fichtner
U. Schwemmer
T. Standl
T. Volk
K. Engelhard
M.F. Stevens
C. Putzke
J. Scholz
M. Zenz
J. Motsch
V. Hempel
A. Heinrichs
B. Zwissler
Publikationsdatum: 01.05.2008
Verlag: Springer-Verlag
Erschienen in: Die Anaesthesiologie / Ausgabe 5/2008
Print ISSN: 2731-6858
Elektronische ISSN: 2731-6866
DOI: https://doi.org/10.1007/s00101-008-1357-3

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Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery

A multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine