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Anesth Analg 2004;99:919-923
© 2004 International Anesthesia Research Society
doi: 10.1213/01.ANE.0000129977.44115.93

REGIONAL ANESTHESIA

Levobupivacaine 0.2% or 0.125% for Continuous Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Comparison with 0.2% Ropivacaine

Andrea Casati, MD*, Federico Vinciguerra, MD*, Gianluca Cappelleri, MD*, Giorgio Aldegheri, MD*, Crispino Grispigni, MD{dagger}, Marta Putzu, MD*, and Paola Rivoltini, MD{dagger}

Departments of *Anesthesiology and {dagger}Orthopedic Surgery, Vita-Salute University of Milano, Instituto di Ricovero e Cura a Carattere Scientifico San Raffaele Hospital, Milan, Italy

Address correspondence and reprint requests to Andrea Casati, MD, Department of Anesthesiology, IRCCS H San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Address e-mail to casati.andrea{at}hsr.it


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
In 60 patients receiving elective hallux valgus repair, we compared the efficacy of continuous popliteal sciatic nerve block produced with 0.2% ropivacaine (n = 20), 0.2% levobupivacaine (n = 20), or 0.125% levobupivacaine (n = 20) infused with a patient-controlled system starting 3 h after a 30-mL bolus of the 0.5% concentration of the study drug and for 48 h (baseline infusion rate, 6 mL/h; incremental dose, 2 mL; lockout time, 15 min; maximum incremental doses per hour, 3). No differences were reported in the intraoperative efficacy of the nerve block. The degree of pain was similar in the three groups throughout the study period, both at rest and during motion. Total consumption of local anesthetic solution during the first 24 h was 148 mL (range, 144–228 mL) with 0.2% ropivacaine, 150 mL (range, 144–200 mL) with 0.2% levobupivacaine, and 148 mL (range, 144–164 mL) with 0.125% levobupivacaine (P = 0.59). The volume of local anesthetic consumed during the second postoperative day was 150 mL (range, 144–164 mL) with 0.2% ropivacaine, 154 mL (range, 144–176 mL) with 0.2% levobupivacaine, and 151 mL (range, 144–216 mL) with 0.125% levobupivacaine (P = 0.14). A smaller proportion of patients receiving 0.2% levobupivacaine showed complete recovery of foot motor function as compared with 0.2% ropivacaine and 0.125% levobupivacaine, both at 24 h (35% vs 85% and 95%; P = 0.0005) and at 48 h (60% vs 100% and 100%; P = 0.001). We conclude that sciatic infusion with both 0.125% and 0.2% levobupivacaine provides adequate postoperative analgesia after hallux valgus repair, clinically similar to that provided by 0.2% ropivacaine; however, the 0.125% concentration is preferred if early mobilization of the operated foot is required.

IMPLICATIONS: Comparing 0.2% ropivacaine with 0.125% and 0.2% levobupivacaine for continuous lateral popliteal sciatic nerve block after hallux valgus repair, this prospective, randomized, double-blinded study demonstrated that both 0.125% and 0.2% levobupivacaine provide effective adequate postoperative analgesia without differences from that provided by 0.2% ropivacaine. If early mobilization of the operated foot is required, the 0.125% concentration of levobupivacaine is preferred rather than 0.2%.


   Introduction
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 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
Although it is usually included among "minor" procedures and is often performed on an outpatient basis, hallux valgus repair induces severe and long-lasting postoperative pain that is difficult to control with standard oral analgesic medications (1) and which benefits from the use of continuous regional analgesia techniques, even in outpatients receiving the infusion at home (2–4).

Bupivacaine and ropivacaine have been extensively investigated for upper and lower limb nerve blocks (2–7), but little is known about the clinical use of the new left isomer levobupivacaine. Continuous interscalene nerve block with 0.125% levobupivacaine has been demonstrated to be effective and safe after open shoulder surgery (8); however, ropivacaine is known to be 40%–50% less potent than bupivacaine, whereas levobupivacaine has almost the same potency as bupivacaine (9,10). The aim of this prospective, randomized, double-blind study was to compare two concentrations of levobupivacaine (0.125% and 0.2%) with 0.2% ropivacaine for continuous sciatic nerve block after hallux valgus repair.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
After we obtained institutional ethics committee approval and patients’ written, informed consent, 60 ASA physical status I–II inpatients undergoing hallux valgus repair under combined sciatic/femoral nerve block were prospectively studied. Patients receiving chronic analgesic therapy and those with contraindications to regional anesthesia, severe cardiopulmonary disease, thyroid disease, diabetes, and central or peripheral neuropathies were excluded.

After IV midazolam premedication (0.05 mg/kg), standard monitoring was placed, including noninvasive arterial blood pressure, electrocardiograph (lead II), heart rate, and oxygen saturation. All nerve blocks were placed by an experienced anesthesiologist with the aid of a nerve stimulator (Plexygon; Vygon, France) with Teflon-coated insulated Tuohy needles (Plexolong; Pajunk, Germany). The stimulation frequency was set at 2 Hz, and pulse duration was set at 0.15 ms; the intensity of stimulating current, initially set at 1 mA, was progressively decreased to ≤0.5 mA before the anesthetic solution was injected.

A femoral nerve block was first performed by using 15 mL of 2% mepivacaine; a popliteal sciatic nerve catheter was then placed by using the lateral popliteal approach (2,11). After a proper needle position was obtained to maintain the same motor response with a current intensity of 0.3–0.4 mA and negative aspiration for blood, 30 mL of either 0.5% ropivacaine or 0.5% levobupivacaine was slowly injected in 5-mL aliquots. A 20-gauge catheter was then introduced 2 to 4 cm from the tip of the Tuohy needle in a cephalad direction and secured with a locking system (Lockit; Portex, Italy) and a transparent TegadermTM dressing.

By using a computer-generated sequence of random numbers, patients were divided into three groups. In the first group, the nerve block was induced with 30 mL of 0.5% ropivacaine and maintained with 0.2% ropivacaine (group ropivacaine; n = 20); in the second and third groups, the nerve block was induced with 30 mL of 0.5% levobupivacaine followed by either 0.125% levobupivacaine (group levo-0.125%; n = 20) or 0.2% levobupivacaine (group levo-0.2%; n = 20). The local anesthetic solutions used to induce and maintain the block after surgery were prepared in a double-blind fashion by one of the authors not taking further part in patient management. The anesthesiologists and pain nurses managing the patients both during and after surgery were blinded to the anesthetic solution used.

The evolution of nerve block was evaluated every 5 min after injection of the anesthetic solution by an independent blinded observer until achievement of adequate sensory block (loss of pinprick sensation in both common peroneal and tibial nerve distribution) and motor block (inability to effectively move the ankle and toes of the operated limb). A hemostatic tourniquet was always placed at the calf and inflated to a pressure of 100 mm Hg higher than the systolic arterial blood pressure. Supplemental sedation during the procedure was provided, if requested by the patient, by using a target-controlled infusion of propofol (target concentrations ranged between 1.2 and 2 µg/mL).

Postoperative analgesia consisted of 100 mg of ketoprofen IV every 8 h and a continuous sciatic nerve block maintained with a patient-controlled analgesia (PCA) infusion pump. The PCA infusion was started 3 h after the induction bolus by using a basal infusion rate of 6 mL/h, an incremental dose of 2 mL, a lockout time of 15 min, and a maximum of three incremental doses per hour (allowing a maximum hourly volume of 12 mL/h). Rescue analgesia was provided with 100 mg of tramadol IV if required despite the use of all PCA boluses to maintain a visual analog scale (VAS) score of ≤4 cm.

The degree of pain was assessed with a 10-cm VAS both at rest and after asking the patient to move the operated foot. Assessment was performed when the PCA sciatic infusion was started, every 8 h for the first 24 h of infusion, and finally after 48 h of infusion. At the same times, the degree of motor block of the operated foot was also evaluated by asking the patient to move the ankle of the operated leg. Motor blockade was evaluated with a two-point scale: 0, persistent motor block—the patient was unable to move the ankle of the operated foot; and 1, recovery of motor function—the patient was able to flex and extend the ankle of the operated foot. If the quality of pain relief was inadequate (VAS >4 cm), irrespective of the maximum volume infused with the PCA pump, a 10-mL bolus of 1% mepivacaine was injected through the catheter, if this proved to be ineffective, the block was considered as failed and the patient was withdrawn. The total consumption of the local anesthetic solution during the 48 h of infusion, the number of incremental doses requested and given by the PCA pump, the need for rescue tramadol, and the occurrence of untoward effects during the study period were recorded. On the second postoperative day, the catheter was removed and the insertion site examined. The orthopedic surgeon then evaluated complete recovery of neurological function 1 wk after the procedure during the routine ambulatory visit.

To calculate the required study size, we considered results from previous studies that evaluated the consumption of local anesthetic solution during the first 24 h of infusion and the proportion of motor block reported during continuous peripheral nerve block with ropivacaine and levobupivacaine (7,8). To detect a 25-mL difference in the volume of local anesthetic solution infused during the first 24 h of infusion with an effect size/standard deviation ratio of 0.9, and accepting a two-tailed {alpha} error of 5% and a ß error of 20%, 20 patients per group were required (12). Moreover, assuming that 24 h after surgery 90% of patients should have complete recovery of motor function when 0.2% ropivacaine is used (7,8), this sample size also allowed us to detect a difference of 40% in the proportion of patients with complete recovery of motor function at the same observation time, accepting a two-tailed {alpha} error of 5% and a ß error of 20% (12).

Statistical analysis was performed with Systat 7.0 (SPSS Inc., Chicago, IL). Normal distribution of the collected data was first verified with the Kolmogorov-Smirnov test. Continuous variables were analyzed with analysis of variance or the Kruskal-Wallis test on the basis of data distribution. Post hoc comparisons were performed with the unpaired Student’s t-test or the Mann-Whitney U-test with Bonferroni’s correction, as indicated. Categorical variables were analyzed with the contingency table analysis and the Fisher’s exact test. P ≤ 0.05 was considered significant. Continuous variables are presented as mean ± SD or median (range) according to data distribution, whereas categorical variables are presented as number (percentage).


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
No differences in age, sex, weight, height, or ASA physical status were observed among the three groups (Table 1). The onset time of surgical block was 28 ± 15 min in group ropivacaine, 34 ± 17 min in group levo-0.2%, and 32 ± 15 min in group levo-0.125% (P = 0.68). Surgery was successfully completed in all studied patients. Propofol sedation was provided to 10 patients of group ropivacaine (50%), 12 patients of group levo-0.2% (60%), and 12 patients of group levo-0.125% (60%) (P = 0.74).


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  		Table 1. Anthropometric Characteristics of Patients Receiving Continuous Sciatic Nerve Block with 0.2% Ropivacaine (Group Ropivacaine; n = 20), 0.2% Levobupivacaine (Group Levo-0.2%; n = 20), or 0.125% Levobupivacaine (Group Levo-0.125%; n = 20)
 
One of 20 patients of group ropivacaine and 2 of 20 patients of group levo-0.2% had technical failure of postoperative analgesia because of accidental removal or dislodgment of the catheter before the first 24 h of infusion was completed (not significant) and were withdrawn from final data analysis. One patient in group ropivacaine and two patients in group levo-0.125% did not complete data collection because they were discharged from the hospital before completing the 48-h observation period (data were recorded until discharge and included the 24-h observation). Postoperative analgesia was excellent in all three groups, without differences among groups. Figure 1 shows the evolution of the VAS in the three groups both at rest and during motion. No differences in the median (range) consumption of local anesthetic solution were observed among the three groups during the first 24 h (group ropivacaine, 148 mL [144–228 mL]; group levo-0.2%, 150 mL [144–200 mL]; group levo-0.125%, 148 mL [144–164 mL]; P = 0.59) or the second postoperative day (group ropivacaine, 150 mL [144–164 mL]; group levo-0.2%, 154 mL [144–176 mL]; group levo-0.125%, 151 mL [144–216 mL]; P = 0.14). Supplemental analgesia with IV tramadol was required by five patients of group ropivacaine (27%), one patient of group levo-0.2% (5.5%), and two patients of group levo-0.125% (11%) (P = 0.16), without differences in total consumption of tramadol among groups.



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  		Figure 1. Degree of pain (mean ± SD) measured at rest (A) and during motion (B) by using a 10-cm visual analog scale (VAS) in patients receiving continuous sciatic nerve block with 0.2% ropivacaine (group ropivacaine; n = 20), 0.2% levobupivacaine (group levo-0.2%; n = 20), or 0.125% levobupivacaine (group levo-0.125%; n = 20).

 
Figure 2 shows the proportion of patients with complete recovery of motor function on the operated leg during the study period. A larger proportion of patients receiving 0.2% levobupivacaine had persistence of motor block compared with the other two groups.



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  		Figure 2. Percentage of patients with complete recovery of motor function during continuous sciatic nerve block with 0.2% ropivacaine (group ropivacaine; n = 20), 0.2% levobupivacaine (group levo-0.2%; n = 20), or 0.125% levobupivacaine (group levo-0.125%; n = 20). 1)One patient of group ropivacaine and two patients of group levo-0.2% did not complete data collection at the 24-h observation time because of accidental catheter removal. 2)One patient in group ropivacaine and two in group levo-0.125% were discharged from the hospital before completing the 48-h observation period.

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
This prospective, randomized, double-blind study showed that both 0.125% and 0.2% concentrations of levobupivacaine provide good postoperative analgesia when continuous lateral popliteal sciatic nerve block is used after hallux valgus repair, with pain relief similar to that produced by 0.2% ropivacaine. However, 0.2% levobupivacaine resulted in more marked motor block as compared with both the 0.125% concentration and the same concentration of ropivacaine, without significant reductions of the volume of the local anesthetic solution administered during the first two postoperative days. This suggests that the 0.125% concentration can be considered a good compromise between adequate pain relief and sensory-motor differentiation.

Although the potency ratio between epidural levobupivacaine and bupivacaine reported during labor is nearly 1 (10), ropivacaine is up to 60% less potent than bupivacaine (9), and similar findings have also been reported during spinal anesthesia (13,14). Comparing the degree of motor block produced by equipotent concentrations of ropivacaine and bupivacaine for continuous interscalene brachial plexus block, Borgeat et al. (7) demonstrated that 0.2% ropivacaine provided similar pain relief but better preservation of motor function than a 0.15% concentration of racemic bupivacaine. Because no previous investigations were reported evaluating the best concentration of levobupivacaine for continuous popliteal sciatic nerve block, we chose an equivalent and equipotent concentration of levobupivacaine as compared with 0.2% ropivacaine. In contrast with Borgeat et al.’s study (7), the present investigation did not show a better preservation of motor function with ropivacaine as compared with an equipotent and equianalgesic concentration of levobupivacaine; increasing the levobupivacaine concentration from 0.125% to 0.2% produced more marked motor blockade but did not improve the quality of postoperative analgesia.

These findings are in agreement with those observed during continuous interscalene brachial plexus analgesia with either 0.125% levobupivacaine or 0.2% ropivacaine (8). However, in contrast with our previous investigation (8), we did not confirm a reduction of local anesthetic consumption in patients receiving levobupivacaine as compared with those treated with 0.2% ropivacaine.

When postoperative evaluation of motor function is considered, it must be noted that Borgeat et al. (7) evaluated the recovery of motor function of the blocked arm by objectively measuring hand grip strength with a bulb grip device connected to an electronic pressure transducer. In the present investigation, motor blockade was more crudely assessed by asking the patient to move the operated foot at the ankle joint, and this probably reduced the sensitivity of our evaluations. Further studies with more objective assessments of motor function, such as electromyographic and mechanical assessment of isometric muscle force, could better quantify this observed difference; nonetheless, our findings are in agreement with previous reports of continuous epidural analgesia (15), which reported no differences in recovery of motor function between 0.2% ropivacaine and 0.125% levobupivacaine. Increasing the concentration of local anesthetics increases the degree of motor blockade during continuous postoperative infusion (16,17).

In conclusion, the results of this prospective, randomized, double-blind study showed that both 0.125% and 0.2% levobupivacaine provide adequate postoperative analgesia after hallux valgus repair, clinically similar to that provided by 0.2% ropivacaine. However, when compared with 0.2% levobupivacaine, the 0.125% concentration should be preferred if early mobilization of the operated foot is required.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

  1. Needoff M, Radford P, Costigan P. Local anesthesia for postoperative pain relief after foot surgery: a prospective clinical trial. Foot Ankle Int 1995; 16: 11–3.[ISI][Medline]
  2. Chelly JE, Greger J, Casati A, et al. Continuous lateral sciatic blocks for acute postoperative pain management after major ankle and foot surgery. Foot Ankle Int 2002; 23: 749–52.[ISI][Medline]
  3. Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo controlled study. Anesthesiology 2002; 97: 959–65.[ISI][Medline]
  4. White PF, Issioui T, Skrivanek GD, et al. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg 2003; 97: 1303–9.[Abstract/Free Full Text]
  5. di Benedetto P, Casati A, Bertini L, et al. Postoperative analgesia with continuous sciatic nerve block after foot surgery: a prospective, randomized comparison between the popliteal and subgluteal approaches. Anesth Analg 2002; 94: 996–1000.[Abstract/Free Full Text]
  6. Tuominen M, Haasio J, Hekali R, Rosenberg PH. Continuous interscalene brachial plexus block: clinical efficacy, technique problems and bupivacaine plasma concentrations. Acta Anaesthesiol Scand 1989; 33: 84–8.[ISI][Medline]
  7. Borgeat A, Kalberer F, Jacob H, et al. Patient-controlled interscalene analgesia with ropivacaine 0.2% versus bupivacaine 0.15% after major open shoulder surgery: the effects on hand motor function. Anesth Analg 2001; 92: 218–23.[Abstract/Free Full Text]
  8. Casati A, Borghi B, Fanelli G, et al. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg 2003; 96: 253–9.[Abstract/Free Full Text]
  9. Capogna G, Celleno D, Fusco P, et al. Relative potencies of bupivacaine and ropivacaine for analgesia in labour. Br J Anaesth 1999; 82: 371–3.[Abstract/Free Full Text]
  10. Lyons G, Columb M, Wilson RC, Johnson RV. Epidural pain relief in labour: potencies of levobupivacaine and racemic bupivacaine. Br J Anaesth 1998; 81: 899–901.[Abstract/Free Full Text]
  11. Casati A, Chelly JE, DiBenedetto P, Fanelli G. Sacral plexus and sciatic nerve. In: Chelly JE, Casati A, Fanelli G, eds. Continuous peripheral nerve block techniques. Segrate, Italy: Mosby, 2001: 67–80.
  12. Browner WS, Black D, Newman B, Hulley SB. Estimating sample size and power. In: Hulley SB, Cummings SR, eds. Designing clinical research: an epidemiologic approach. Baltimore: Williams & Wilkins, 1988: 139–50.
  13. McDonald SB, Liu SS, Kopacz DJ, Stephenson CA. Hyperbaric spinal ropivacaine: a comparison to bupivacaine in volunteers. Anesthesiology 1999; 90: 971–7.[ISI][Medline]
  14. 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]
  15. Casati A, Santorsola R, Aldegheri G, et al. 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 2003; 15: 126–31.[ISI][Medline]
  16. Murdoch JA, Dickson UK, Wilson PA, et al. The efficacy and safety of three concentrations of levobupivacaine administered as a continuous epidural infusion in patients undergoing orthopedic surgery. Anesth Analg 2002; 94: 438–44.[Abstract/Free Full Text]
  17. Zaric D, Nydahl PA, Philpson L, et al. The effect of continuous lumbar epidural infusion of ropivacaine (0.1%, 0.2%, 0.3%) and 0.25% bupivacaine on sensory and motor block in volunteers. Reg Anesth 1996; 21: 14–25.[ISI][Medline]
Accepted for publication April 5, 2004.




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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press