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Anesth Analg 2004;98:389-394
© 2004 International Anesthesia Research Society
doi: 10.1213/01.ANE.0000093389.80111.02

PAIN MEDICINE

Epidural Levobupivacaine 0.1% or Ropivacaine 0.1% Combined with Morphine Provides Comparable Analgesia After Abdominal Surgery

Marc Senard, MD*, Abdourhamane Kaba, MD*, Murielle J. Jacquemin, MD*, Luc M. Maquoi, MD*, Marie-Pierre N. Geortay, MD*, Pierre D. Honoré, MD{dagger}, Maurice L. Lamy, MD*, and Jean L. Joris, MD PhD*

*Department of Anesthesia and Intensive Care Medicine and {dagger}Service of Abdominal Surgery, CHU de Liège, Belgium

Address correspondence to Dr. Jean Joris, Department of Anesthesia and Intensive Care Medicine, CHU Sart Tilman, B-4000 Liège, Belgium. Address e-mail to jean.joris{at}chu.ulg.ac.be


   Abstract
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 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
Ropivacaine appears attractive for epidural analgesia because it produces less motor block than racemic bupivacaine. The potential benefits of levobupivacaine with regard to motor blockade require further investigations. In this study, we compared the efficacy, dose requirements, side effects, and motor block observed with epidural levobupivacaine and ropivacaine when given in combination with small-dose morphine for 60 h after major abdominal surgery. Postoperatively, 50 patients were randomly allocated, in a double-blinded manner, to patient-controlled epidural analgesia with the same settings and without basal infusion, using 0.1% levobupivacaine or 0.1% ropivacaine. Both were combined with an epidural infusion of 0.1 mg/h morphine. Pain scores, side effects, motor block, and local anesthetic consumption were measured for 60 h. Pain scores measured on a 100-mm visual analog scale were approximately 20 mm at rest and 40 mm during mobilization in both groups. Bromage scores were 1 for all patients after the fourth postoperative hour. Consumption of levobupivacaine and ropivacaine were similar: 344 ± 178 mg levobupivacaine versus 347 ± 199 mg ropivacaine 48 h postoperatively. On postoperative day 2, 19 patients in the ropivacaine group versus 12 in the levobupivacaine group were able to ambulate (P < 0.05). No difference was noted concerning incidence of side effects. We conclude that when used as patient-controlled epidural analgesia and combined with small-dose epidural morphine, 0.1% levobupivacaine and 0.1% ropivacaine produce comparable postoperative analgesia with a similar incidence of side effects.

IMPLICATIONS: Small concentrations (0.1%) of epidural levobupivacaine and ropivacaine combined with morphine (0.1 mg/h) produce comparable analgesia and have similar side effects for similar dose requirements.


   Introduction
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 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
Postoperative epidural analgesia with local anesthetics may improve patient outcome after major abdominal surgery (1,2). Early mobilization and ambulation accelerate postoperative recovery (3), but require no motor blockade. Ropivacaine is reported to produce less motor blockade than racemic bupivacaine (4–6). Only one clinical study using combined spinal-epidural analgesia during labor also suggests less motor blockade with levobupivacaine (7). This makes these new local anesthetics appealing for postoperative epidural analgesia.

However, the doses of epidural ropivacaine required to provide analgesia alone after abdominal surgery result in significant motor block in 30% of patients with high lumbar epidural catheters (8). The use of a small concentration (<=0.1%) of ropivacaine solution combined with opioid provides effective postoperative analgesia and reduces the incidence of motor blockade (9). Similarly, when used alone, epidural levobupivacaine at concentrations of 0.125% and larger produces adequate analgesia, but results in a significant incidence of motor blockade (10). The combination of 0.125% or 0.25% levobupivacaine with fentanyl (11) or small-dose morphine (12) improves the quality of postoperative analgesia but does not completely prevent motor blockade. Further reduction of levobupivacaine concentration is therefore probably necessary to provide analgesia without motor blockade as reported for labor analgesia (13).

In a previous study (14), we showed that, when administered with small-dose epidural morphine, similar doses of 0.1% ropivacaine and 0.1% racemic bupivacaine are required to provide adequate analgesia, and have similar side effects. Levobupivacaine and racemic bupivacaine are also considered equipotent (15); therefore, we tested the hypothesis that analgesia, side effects, and dose requirements of 0.1% levobupivacaine and 0.1% ropivacaine combined with small-dose epidural morphine are similar after abdominal surgery.


   Methods
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 Abstract
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 Methods
Results
 Discussion
 References
 
With approval of our Institution Ethics Committee and informed consent, in this randomized double-blinded study, we studied 50 ASA physical status I–III patients scheduled for elective major abdominal surgery.

The patients fasted at least 6 h and were orally premedicated with 50 mg of hydroxyzine and 0.5 mg of alprazolam 2 h before surgery. An IV infusion of Ringer’s lactate solution (10 mL · kg-1 · h-1) was given throughout surgery. An epidural catheter was inserted at the T8–9 to T9–10 interspace. After an epidural test dose (4 mL of 1% lidocaine with 1/200,000 epinephrine), 0.1 mL/kg of 0.5% levobupivacaine was injected and a continuous epidural infusion of 0.25% levobupivacaine (0.1 mL · kg-1 · h-1) was started. Intraoperatively, we used levobupivacaine in all patients to obtain the same postoperative recovery from epidural anesthesia. General anesthesia was induced with propofol using a target continuous infusion set at 3 µg/mL and 0.25 µg · kg-1 · min-1 remifentanil. Propofol was adjusted to maintain the bispectral index® of the encephalogram score between 45 and 55 (Aspect Medical Systems, Newton, MA). The dose of remifentanil was adapted in response to the hemodynamic changes secondary to surgical stimulation.

Patients were ventilated with a 50% oxygen/air mixture. Orotracheal intubation was facilitated and intraoperative muscle relaxation was performed with cisatracurium. One hour before the end of surgery, propacetamol (2 g) was given IV and then systemically every 6 h. Propacetamol is a precursor of paracetamol (Pro-Dafalgan®, UPSA Medica, Belgium; 2 g of propacetamol = 1 g of paracetamol or acetaminophen in the United States).

General anesthesia was discontinued at the end of surgery, and the epidural infusion of 0.25% levobupivacaine was stopped. Patients were then randomly allocated in a double-blinded manner to 2 groups (n = 25 each). In the first group, 0.1% ropivacaine was given epidurally, and epidural 0.1% levobupivacaine was given to the second.

The local anesthetic solution was prepared in 500-mL bags by the pharmacy according to a computer-generated randomization list. It was administered for 60 postoperative hours using a patient-controlled epidural analgesia (PCEA) pump (Baxter I pump AP II; Baxter Healthcare Co., Deerfield, IL). PCEA settings were the same in both groups: bolus dose of 5 mL, lockout interval of 10 min, and no basal infusion. PCEA was combined with a continuous epidural infusion of 0.1 mg/h morphine. Morphine was not mixed with the local anesthetic solution to keep the dose of morphine independent of the amount of local anesthetic administered. Rescue analgesia was provided with an IV infusion of 100 mg of tramadol every 6 h if necessary. The epidural catheter was removed on the third postoperative day.

Pain and motor block were evaluated 4 h after the end of surgery, and at 08:00, 13:00, and 18:00 on the first and second postoperative days. Pain was scored on a 100-mm visual analog scale (VAS) at rest, during mobilization from the supine to the sitting position, and when coughing. The sensory block level was assessed using the cold test with ether swabs. Motor block was assessed with the Bromage scale (1 = no motor block, 2 = knee blocked and mobility of ankle preserved, 3 = mobility of ankle difficult, 4 = knee and ankle blocked). To explore the strength of the anterior abdominal wall muscles, we measured how long (up to 10 s) the patients could hold both legs extended above the plane of the bed while lying supine in the bed.

Consumption of local anesthetic was recorded every 4 h, and the need for rescue analgesic noted. Once a day while the patient was sitting in an armchair, we evaluated orthostatic hypotension on a 5-point scale (0 = systolic arterial blood pressure [SABP] > 100 mm Hg; 1 = 80 < SABP < 100 mm Hg without dizziness; 2 = 80 < SABP < 100 mm Hg with dizziness; 3 = SABP < 80 mm Hg without dizziness and resolved with a rapid perfusion of 500 mL of Ringer’s lactate solution; and 4 = SABP < 80 mm Hg with vertigo or resistant to fluid challenge). The ability to walk 5 m with assistance was tested once a day the first and second postoperative days.

Opioid-related side effects were also recorded. Nausea, vomiting, and pruritus were evaluated on a 100-mm VAS and treated, at patient request, with 2 mg of IV tropisetron, a 5-HT3 receptors antagonist (Novaban®; Novartis Pharma, Brussels, Belgium). Ward nurses evaluated sedation scores (0 = awake, 1 = drowsy, 2 = asleep, 3 = unconscious) and respiratory rate every 4 h; respiratory depression was defined by a respiratory rate of <12 breaths/min. Because of the systematic use of an indwelling bladder catheter, urinary retention was not reported.

The time to first flatus and duration of hospitalization were also recorded. Finally, patient satisfaction of postoperative analgesia was assessed on a 100-mm VAS, with 100 mm indicating complete satisfaction.

Our estimated sample size was based on anticipated epidural levobupivacaine consumption. A previous study (14) using a similar protocol indicated that the mean PCEA use of racemic bupivacaine over 48 h would be 310 mg with a SD of 116 mg. Considering racemic bupivacaine and levobupivacaine as equipotent (15), 24 patients per group provided an 80% power for detecting a 30% difference for local anesthetic consumption between the groups, at an {alpha} level of 0.05.

Continuous variables are presented as mean ± SD and categorical variables are represented as numbers, unless otherwise noted. Continuous variables were compared with repeated measures analysis of variance or Student’s t-test, as appropriate. Categorical data were analyzed with {chi}2 tests. A value of P <= 0.05 was considered significant.


   Results
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Demographic and intraoperative data as well as the types of surgery were similar in the two groups (Table 1).


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  		Table 1. Patient Data
 
Pain scores at rest, during mobilization, and when coughing were similar in both groups (Fig. 1). Extension of sensory block did not differ in the 2 groups: the upper level ranged between T4–T5 and the lower levels between L1–L3 during the observation period. Consumption of levobupivacaine and ropivacaine were similar (Fig. 2). Doses of 0.1% levobupivacaine and 0.1% ropivacaine required to provide postoperative analgesia ranged from 8 to 9 mg/h during the first 12 postoperative hours and approximately 7 mg/h thereafter. The need for rescue analgesics was also similar (Table 2).



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  		Figure 1. Pain scores at rest, during mobilization, and when coughing on a 100-mm visual analog scale (VAS). Data are presented as mean ± SEM.

 


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  		Figure 2. Local anesthetic (LA) consumption after surgery. Data are presented as mean ± SEM.

 

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  		Table 2. Secondary Outcomes
 
No patient from either group had a motor block when assessed on the Bromage scale after the fourth postoperative hour. Performance of the leg-lift test was similar in the two groups (Fig. 3). Hypotension occurred in approximately 20% of the patients in each group (Table 2); however, all the hypotensive episodes were resolved after an accelerated infusion of 500 mL of Ringer’s lactate solution. On the second postoperative morning, the ropivacaine group had a larger percent of patients who were ambulatory (76% versus 48%, P = 0.041) (Table 2).



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  		Figure 3. Time patients were able to hold legs extended in leg-lift test. Data are presented as mean ± SEM.

 
The incidence of pruritus (32%) and nausea (36%) was similar in the 2 groups. Respiratory depression was not detected in either group. Sedation scores were similar in the groups; all patients had a daytime sedation score of 1 or 2. Finally, time to first flatus, duration of hospitalization, and satisfaction scores were similar in the groups (Table 2).


   Discussion
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 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
No clinical studies have compared ropivacaine and levobupivacaine for postoperative epidural analgesia. This study demonstrates that epidural 0.1% ropivacaine and 0.1% levobupivacaine combined with a small dose of morphine produce similar analgesia at rest, during mobilization, and when coughing. Dose requirements of both local anesthetics at that concentration are not significantly different. Finally, in the conditions of our study, the doses of each local anesthetic required to produce adequate postoperative epidural analgesia resulted in a similar incidence of side effects.

Patients from each group reported similar pain scores at rest, during mobilization, and coughing. Because patients were provided with a PCEA, they were able to titrate the analgesic to obtain satisfactory pain relief. It is therefore not surprising that pain scores at rest were not different with the two local anesthetics. Furthermore, the sensory blockade achieved with both local anesthetic solutions was comparable.

The dose of levobupivacaine required to obtain analgesia is slightly smaller than previously reported (12). However, in the previous study, patients received more concentrated (0.25%) levobupivacaine combined with morphine and the local anesthetic administration was not patient controlled but adjusted by the investigators. The use of PCEA in our study, which reduces local anesthetic consumption during surgery (16) or during labor (17), may have contributed to these differences.

During the past few years, attention has focused on early mobilization and ambulation as part of an acute rehabilitation program to accelerate postoperative recovery (3). It is therefore mandatory that the local anesthetic used postoperatively produces analgesia without motor block. As compared with racemic bupivacaine, epidural ropivacaine at <=0.3% reduces the incidence of motor blockade and shortens its duration during labor (18) or postoperatively (19). Experimental studies reported that levobupivacaine produces less motor block than racemic bupivacaine (20). Only one clinical study comparing levobupivacaine and racemic bupivacaine for labor analgesia using a combined spinal-epidural technique suggested a decreased incidence of motor block with intrathecal levobupivacaine (7). The amount of epidural ropivacaine required to provide good pain relief when given alone or after abdominal surgery (20 mg/h) is still associated with a significant risk of motor block (8). However, combining it with fentanyl (21), sufentanil (22), or morphine (14) halves the ropivacaine requirement and decreases the incidence of motor block compared with equianalgesic doses of racemic bupivacaine. Liu et al. (9) showed that a large volume of a dilute solution of ropivacaine produces less motor block than the same dose of ropivacaine given as a more concentrated solution. Moreover, reducing the concentration reduces the dose requirements of ropivacaine (14,21). All these studies favor using a dilute solution of ropivacaine with small-dose opioids, as used in the present study. However, a recent study using levobupivacaine reported less motor block with a small volume of concentrated solution (0.5%) than with a large volume of more dilute solution (0.15%) (23).

We used a small concentration of ropivacaine and levobupivacaine. Equianalgesic doses of each local anesthetic were given because administration was patient-controlled (and without continuous infusion). Accordingly, patients reported similar pain scores in each group. We did not find any differences between levobupivacaine and ropivacaine in motor blockade. When using the Bromage scale, we found no motor block in the 0.1% levobupivacaine and 0.1% ropivacaine groups after the fourth postoperative hour. We used the leg-lift test to assess motor blockade of the abdominal wall muscles, which are located in the dermatomes blocked by thoracic epidural analgesia. Pain evoked by contraction of these muscles injured by surgical incision probably affects the performance of this test. Nevertheless, no significant differences were detected between the groups.

The incidence of hypotension was infrequent and similar in the two groups. The incidence of mild orthostatic hypotension was not different from that reported in other studies (8,14) and was even less frequent than reported in a study using 0.25% levobupivacaine (12). All our hypotensive episodes were transient, quickly resolved by accelerating the infusion rate of crystalloids, and did not prevent the patient from sitting in an armchair. It is not unusual for patients who have had major abdominal surgery to experience orthostatic hypotension the day after surgery, even in the absence of epidural analgesia with local anesthetic. Because all our patients were given epidural local anesthetic, it is impossible to determine the respective contributions of epidural analgesia and surgery to the incidence of orthostatic hypotension.

We also assessed the ability to walk on the first and second postoperative days. More patients from the ropivacaine group were able to walk on day 2. These data do not allow us to firmly state that this difference is clinically significant because we only tested our patients for the first two postoperative days. Whether this difference would persist longer is not known. However, Brodner et al. (19), when comparing ropivacaine and racemic bupivacaine, reported that more patients given ropivacaine were able to walk on the second postoperative day and that the difference between the two groups persisted until the fourth postoperative day. Persistence of impaired functional balance with inadequate muscle tone and coordination after total recovery of motor block (24) and orthostatic hypotension may explain why some patients were unable to walk. Ability to walk (time and distance) could be a primary end-point for further studies assessing adequacy of a local anesthetic for epidural analgesia as part of an active rehabilitation protocol. Finally, other variables assessing the quality of postoperative recovery, such as time to first flatus, duration of hospitalization, and patient satisfaction, were also similar in the two groups.

We selected a very small dose of morphine without an initial loading dose. Indeed, in a pilot study, we found that the intraoperative epidural administration of a bolus injection of 2 mg of morphine followed by a continuous infusion of 0.2 mg/h morphine, as used by Kehlet and Morgensen (25), resulted in almost no patient consumption of local anesthetic. Accordingly, Dahl et al. (26) reported similar pain scores at rest when patients were treated with the same dose of epidural morphine alone or combined with a continuous infusion of bupivacaine. Moreover, the administration of epidural opioid can result in side effects such as pruritus, hypotension, respiratory depression, and oxygen desaturation. We therefore chose a dose of morphine (0.1 mg/h) that requires the use of local anesthetic to produce satisfactory analgesia. This enabled us to detect potential differences in the requirements of the two local anesthetics tested. Not surprisingly, we did not observe any serious opioid-related side effects. This small dose of epidural morphine was nevertheless effective because ropivacaine and levobupivacaine requirements were less than those reported in studies using these local anesthetics alone after surgery (8).

The potency ratio between ropivacaine and racemic bupivacaine has been the subject of many debates. When large concentrations are administered, the potency ratio between ropivacaine and racemic bupivacaine is approximately 0.67 (27). When small concentrations are given (<=0.125%) and the local anesthetic is combined with opioids, ropivacaine and bupivacaine are clinically equianalgesic (14,28–30). The potency ratio between levobupivacaine and racemic bupivacaine is also close to 1 (15), if the concentration of levobupivacaine is expressed as milligrams/milliliter base (as in commercially available preparations) and not as milligrams/milliliter levobupivacaine hydrochloride (as in racemic bupivacaine preparations) (31). It is therefore not surprising that 0.1% levobupivacaine and 0.1% ropivacaine were found equianalgesic.

In conclusion, dose requirements of 0.1% levobupivacaine or 0.1% ropivacaine combined with small doses of epidural morphine and administered with PCEA at the thoracic level range between 7 and 9 mg/h after abdominal surgery. In these conditions, both local anesthetics are equianalgesic and have similar side effects.


   Footnotes
 
Presented in part at the annual meeting of the European Society of Anaesthesiologists, Glasgow, May 31–June 3, 2003.


   References
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

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Accepted for publication August 14, 2003.




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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