Anesth Analg 1999;89:111
© 1999 International Anesthesia Research Society
REGIONAL ANESTHESIA AND PAIN MANAGEMENT
Ropivacaine Epidural Anesthesia and Analgesia Versus General Anesthesia and Intravenous Patient-Controlled Analgesia with Morphine in the Perioperative Management of Hip Replacement
H. Wulf, MD*,
J. Biscoping, MD
,
B. Beland, MD
,
B. Bachmann-Mennenga, MD§,
J. Motsch, MD, and
and the Ropivacaine Hip Replacement Multicenter Study Group1
Departments of Anesthesiology and Intensive Care Medicine, University Hospitals of
*Kiel,
Münster, and Heidelberg; and
St.Vincentius Hospital Karlsruhe,
§Klinikum Minden, Germany
Address correspondence and reprint requests to Hinnerk Wulf, MD, Department of Anesthesiology and Intensive Care Medicine, Hospital of the Christian-Albrechts-University Kiel, Schwanenweg 21, D 24105 Kiel, Germany. Address e-mail to wulf{at}anaesthesie.uni-kiel.de
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Abstract
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The aim of our study was to compare epidural anesthesia and analgesia (EDA) with ropivacaine versus general anesthesia followed by IV patient-controlled analgesia with morphine (GA/PCA) after hip replacement regarding pain, side effects, and discharge from the postanesthesia care unit. After ethics committee approval, randomization, and informed consent, 90 patients were enrolled. In Group EDA, epidural anesthesia (ropivacaine 10 mg/mL, 15–25 mL) was followed by an epidural infusion (2 mg/mL, 4–6 mL/h for 24 h, plus top-up doses of 6–10 mL for 48 h). GA/PCA patients received general anesthesia (isoflurane/N2O/fentanyl) followed by IV patient-controlled analgesia with morphine postoperatively. Pain was assessed by using visual analog scales (0–100 mm) at rest and during physiotherapy. Pain at rest was less in the EDA (n = 43) group than in the GA/PCA (n = 45) group (at 10 h: 11.8 ± 12.9 vs 28.4 ± 17.1 [P < 0.001]; at 24 h: 14.3 ± 11.7 vs 24.0 ± 17 [P < 0.01]; in 48 h: 14.3 ± 9.3 vs 21.1 ± 17.4 [P = 0.1]). Whereas EDA patients were deemed ready for discharge from the postanesthesia care unit earlier than GA/PCA patients (5.6 ± 8.9 vs 39.7 ± 41.5 min), the actual discharge time was comparable. The median time for first passage of flatus was shorter in the EDA group than in the GA/PCA group (26 vs 47 h). Nausea and vomiting were more common in the GA/PCA group than in the EDA group (16% vs 28% and 11% vs 22%, respectively), whereas hypotension (11% vs 4%) and bradycardia (14% vs 2%) were less frequent. Under the conditions of the present study, EDA with ropivacaine provided pain control after hip replacement superior to that provided by IV patient-controlled analgesia with morphine, particularly during the first 24 h. Both approaches to pain management were equally safe.
Implications: Compared with general anesthesia and postoperative IV patient-controlled analgesia with morphine, epidural anesthesia and analgesia with the new local anesthetic ropivacaine enables patients to be discharged sooner from a postanesthesia care unit and provides superior pain relief during the first 24 h after hip replacement.
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Introduction
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Postoperative recovery after major surgery depends on various factors, such as pain relief, nausea, mobilization, and gastrointestinal (GI) function. Despite advances in the knowledge of acute pain mechanisms and treatment, management of acute pain is often ineffective, especially on general wards (1). Opioids remain the most common treatment for postoperative pain, but some patients continue to experience pain (2). More recently, patient satisfaction with opioids has improved with the introduction of patient-controlled analgesia (PCA). Nevertheless, according to a meta-analysis comparing PCA with conventional treatment (3), outcome was not improved by IV opioid PCA. This could be due, in part, to the well recognized opioid-related adverse events (nausea, sedation, constipation, and respiratory depression) that may affect postoperative recovery.
The use of epidural analgesia, especially with local anesthetics, has been suggested to accelerate the recovery of GI function through blockade of inhibitory sympathetic reflexes (4–6). Retrospective evaluations suggest that epidural analgesia results in better analgesia with fewer side effects compared with PCA (7), although postoperative recovery using different approaches to anesthesia and postoperative pain management has not been evaluated systematically.
The aim of the present study was to evaluate pain and recovery after two treatment approaches: general anesthesia followed by PCA-morphine (GA/PCA) and epidural anesthesia followed by epidural analgesia with ropivacaine (EDA).
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Methods
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After ethics committee approval and written, informed consent, patients >18 yr old, ASA physical status I—III, scheduled for unilateral total hip replacement were included in this prospective, randomized clinical study. Exclusion criteria were contraindications to epidural anesthesia or the study drugs, suspected inability to comply with the study procedures (e.g., physiotherapy on the day after surgery), and suspected significant alcohol or drug abuse. Lactating or pregnant women were also excluded.
In Group EDA, an epidural catheter was inserted at L3-4 preferentially, using loss of resistance to saline. Five minutes after a 3-mL test dose of 20 mg/mL lidocaine, a 12- to 15-mL main dose of ropivacaine 10 mg/mL was administered. Midazolam could be used for sedation intraoperatively in aliquots of 1 mg. If adequate sensory block (upper limit below T10) was not achieved after 30 min, an additional 5–10 mL of ropivacaine was injected. If sensory or motor block was not adequate after 45 min, the patient could receive another anesthetic regimen. Additional 5-mL doses could be injected at signs/symptoms of inadequate block or regression of block. During the entire surgical procedure, a maximal dose of 250 mg of ropivacaine was allowed.
Patients in the GA/PCA group received general anesthesia induced with thiopental or etomidate, fentanyl, and a nondepolarizing muscle relaxant. Anesthesia was maintained with isoflurane/enflurane, fentanyl, nitrous oxide/oxygen, and muscle relaxation. The dose of fentanyl was limited to 3 µg/kg body weight for induction and 2 µg · kg body weight-1 · h-1 for maintenance.
In the EDA group, an epidural infusion of ropivacaine 2 mg/mL was commenced as soon as regression of motor block (Bromage score 
2) was obvious. The infusion was run at a rate of 4–6 mL/h (8–12 mg/h) and was kept constant during the first 24 h. Whenever the patient requested additional pain relief, a 6-mL (12 mg) top-up dose was administered, with a minimum of 30 min between each top-up. The continuous infusion was discontinued after 24 h, top-ups of 20 mg were administered at the discretion of the investigator, and the epidural catheter withdrawn after 48 h.
In the GA/PCA group, up to 10 mg of IV morphine could be administered as a loading dose before PCA. The device was set to deliver 1.0 to 1.5-mg IV bolus doses of morphine, with a 5-min lockout time. PCA was disconnected 48 h after arrival in the postanesthesia care unit (PACU). In the PACU, IV morphine was used as a rescue analgesic, whereas metamizole, a nonopioid, was used on general wards. After disconnection of the EDA or PCA (48 h), analgesic therapy was continued with an oral nonsteroidal antiinflammatory drug (diclofenac).
Motor block was determined bilaterally according to a modified Bromage scale, and criteria for discharge from the PACU were documented every 15 min until a total score of 9–12 was achieved [modified Aldrete score (8)]. Patients were evaluated at least twice daily and were deemed ready for discharge when the following criteria were met simultaneously: return of bowel motility (passage of first flatus), oral nutrition tolerated without discomfort, urinary function resumed, satisfactory pain control with oral analgesics, normal body temperature, mentally clear and cooperative, and ability to ambulate with or without a simple mechanical supporting device. The time that the patient was actually discharged from the hospital was also documented.
The primary efficacy variable (clinical outcome) was area under the curve (AUC; in mm) based on the visual analog scale (VAS) measurements for pain at rest. Time zero for the clinical assessments was arrival in the PACU. For repeated assessments of pain scores (VAS 0–100 mm), a summary measure of the repeated measurements during the 24-h postoperative period was used. First, the AUC based on the repeated measurements up to 24 h was calculated using the trapezoidal rule. The summary measure considered was then defined as that AUC divided by the length of the time on which it was based, so that it had the same scale as the VAS. This summary measure was denoted AUCM24.
Secondary efficacy variables were: AUCM10 and AUCM48 (defined in analogy to AUCM24); indicator of VAS measurement for pain at rest 
30 mm; pain on mobilization; time at which patients were deemed ready for discharge, including time until return of bowel function; adverse events, including postoperative nausea and vomiting (PONV); and degree of motor block.
Stratified Wilcoxon mid(rank) sum test, two-sided, was used wherever appropriate. 
was set at 0.05. Descriptive statistics and graph (box plots) are offered. Data are presented as median or mean ± SD (range).
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Results
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Of the 90 enrolled Caucasian patients, 44 (25 female) were randomized to the EDA group and 46 (21 female) to the GA/PCA group (Table 1). There was no significant difference in biometric data or ASA physical status.
Of the 90 patients, 43 in the EDA group and 45 in the PCA group were eligible for the intention-to-treat (ITT) analysis, and 38 patients in the EDA group and 45 patients in the PCA group were eligible for the per-protocol analysis. The two patients excluded from the ITT were one in the EDA group, in whom no sensory and motor block was achieved and who received GA, and one patient of the GA/PCA group who had been scheduled for surgery but was withdrawn by the surgeon. During surgery in the EDA group, sedation was achieved in 36 of 44 patients by using midazolam. Premature discontinuation of treatment was observed in five (11%) patients of the EDA group (displacement of the catheter in three patients and patient's request in two cases). Ropivacaine 174 ± 56 mg was administered for surgery and 358 ± 169 mg was administered in the further postoperative course (Table 2). In the GA/PCA group, the total dose of PCA morphine was 50 ± 28 mg (7–134 mg), and the number of attempts was 48 ± 28 (7–134) in 48 h.
Additional postoperative analgesics were documented for 89% patients in the EDA group and for all patients in the GA/PCA group. On the day of operation, 9% of patients in the EDA group received morphine. In the GA/PCA group, 67% of patients received morphine in addition to PCA morphine. During the first 2 postoperative days, 46% of patients in the EDA group received metamizole (mean dose 2.6 ± 2.0 g [0.33–8.0 g]), compared with 31% in the GA/PCA group (mean dose 1.3 ± 1.0 g [0.33–3.8 g]). From the third postoperative day, diclofenac was administered to 65% versus 64% of patients in the EDA versus GA/PCA groups.
The mean AUCM24 for wound pain at rest was significantly lower in the EDA group (14 ± 12 [0–38] mm) compared with the GA/PCA group (24 ± 17 [3–78] mm) in the primary ITT analysis (P = 0.007) (Fig. 1). Patients with a VAS score >30 mm at rest were found significantly more often in the GA/PCA group (Table 3).
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Figure 1. Pain at rest after total hip replacement in the epidural analgesia with ropivacaine 2 mg/mL (EDA) versus postoperative analgesia with morphine IV patient-controlled analgesia (GA/PCA) groups. Pain scores were evaluated using a 0–100 visual analog scale. For repeated assessments, a summary measure during the postoperative period was used. First, the area under the curve based on the repeated measurements was calculated using the trapezoidal rule, e.g., up to 24 h. The summary measure considered was then defined as that area under the curve divided by the length of the time on which it was based, so that it had the same scale as the underlying repeated measurements. This summary measure was denoted AUCM24. AUCM10 for 10 h and AUCM48 for 48 h were obtained in an identical manner. Data for the EDA group (•) are shown on the left and data for the GA/PCA group ( ) are shown on the right. Data are presented as box plots with median (horizontal line within the box), first and third quartiles (box), 10 and 90 percentiles (bars) and extreme values (single symbols).
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Initially, higher mean values for pain at mobilization were reported in the GA/PCA group (Fig. 2): VAS scores after mobilization for the EDA and GA/PCA groups were 32 ± 24 vs 39 ± 21 (Day 1, 8–10 AM), 31 ± 23 vs 43 ± 23 (Day 1, 4–6 PM), and 26 ± 21 vs 30 ± 21 (Day 2, 8–10 AM).
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Figure 2. Pain during mobilization after total hip replacement in the epidural analgesia with ropivacaine 2 mg/mL versus postoperative analgesia with morphine IV patient-controlled analgesia groups. Pain scores were evaluated using a 0–100 visual analog scale (VAS) and are presented as box plots. Data for the EDA group (•) are shown on the left and data for the GA/PCA group () are shown on the right. Data are presented as box plots with median (horizontal line within the box), first and third quartiles (box), 10 and 90 percentiles (bars) and extreme values (single symbols).
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More than half of the patients in the EDA group were deemed ready for discharge from the PACU at the time of arrival in the PACU, or even before arrival. Mean and median time until patients were deemed ready for discharge from the PACU was shorter in the EDA group in all centers. The time at which patients were deemed ready for discharge from the PACU was considerably shorter than the time patients actually spent in the PACU (Table 4). Compared with the GA/PCA group, the median time until the return of bowel motility (first flatus) was shorter in the EDA group (26 vs 47 h), and nausea and vomiting was reported less frequently during the first 10 h (16% vs 28% and 11% vs 22%, respectively). Patients in the EDA group were mentally clear and cooperative earlier than those in the GA/PCA group, but actual discharge times from hospital did not differ significantly (Table 4). Three patients in the GA/PCA group developed complications that required a prolonged hospital stay. Five such complications were reported in the EDA group, and three serious complications occurred in the GA/PCA group. No patient died in the course of the study. All serious complications were regarded as typical complications of surgery (e.g., wound infection).
The mean duration from administration of the main epidural dose until achieving sensory block at T10 was 18 ± 14 min (4–50 min). The time spent in the anesthesia induction area, which included insertion of the epidural catheter and test dose, was significantly longer in the EDA group (60 ± 22 min) compared with the GA/PCA group (37 ± 22 min). The operating room time per se showed no difference (145 ± 45 vs 136 ± 29 min). No measurable motor block was detectable in most patients 5–9 h after the administration of the main epidural dose onward; therefore, it did not influence mobilization. Four patients from Center 4 had a somewhat prolonged recovery from motor block: Bromage grade 1 disappeared after 12–52 h.
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Discussion
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Our objective was to compare two approaches to anesthesia and postoperative pain management: EDA versus GA/PCA. Patients treated with epidural ropivacaine experienced less pain, especially in the first 24 h postoperatively.
No clinically relevant difference was found with regard to pain after mobilization or the need for additional analgesics. This could be due to the change from continuous epidural infusion to PRN boluses after 24 hours. In addition, pain intensity after hip replacement decreases rapidly (confirmed by the low patient-controlled consumption of morphine in the present study), whereas after total knee replacement, advantages of ropivacaine EDA versus IV morphine PCA can be demonstrated more clearly due to more painful physiotherapy (9). Therefore, differences in the efficiency of postoperative pain management after hip replacement might be difficult to demonstrate beyond this period. The data from the present multicenter study are in accordance with the results of other studies indicating the advantages of EDA compared with today's "gold standard" of postoperative pain relief (IV PCA opioids), e.g., after upper abdominal surgery (10). In the present study, these advantages were obtained despite the fact that the IV opioids were given on a PCA basis, whereas the epidural management was more conventional (continuous infusion and/or top-up injections) instead of patient-controlled epidural analgesia (11). This management of short-term local anesthetics is not very consistent with common clinical practice and was chosen because of the very limited experience with epidural ropivacaine at that time. Future studies are required to demonstrate whether the combination of ropivacaine with epidural opioids further improves pain management.
In experimental studies, S-ropivacaine produces less motor block and fewer cardiotoxic effects than bupivacaine (12). Epidural ropivacaine 2 mg/mL resulted in excellent analgesia without significant motor block after major orthopedic (13,14) or abdominal surgery (15,16). In volunteers, IV ropivacaine produced less central nervous system toxicity than bupivacaine on a per-milligram basis and fewer signs of cardiotoxicity even in terms of equipotent dosing (17). Only minor side effects have been reported in patients, and free, as well as total, plasma concentrations stayed well below the potential threshold for systemic toxicity (14), which indicates that prolonged EDA with ropivacaine 2 mg/mL is an efficient and safe procedure.
Only minor differences were observed with regard to GI symptoms. Overall nausea (reported in 15 EDA versus 18 GA/PCA patients) and vomiting (13 EDA versus 14 GA/PCA patients) occurred in approximately the same number of patients. However, in the 10 hours after arrival in the PACU, nausea was more common in the GA/PCA group versus the EDA group (7 EDA versus 13 GA/PCA patients) and is a common adverse event that may be related to treatment with PCA morphine. In the case of low opioid consumption, specific side effects such PONV are rare, and a significant difference to epidural analgesia will hardly show. Therefore, both approaches to postoperative pain management were well tolerated and safe.
According to the standardized criteria, patients in the EDA group were deemed ready for discharge from the PACU earlier than patients in the GA/PCA group. However, the time that the patients actually spent in the PACU was comparable in both groups and mainly depended on the institutional policy of the participating centers. Routine postoperative care was provided according to the requirements for patients after general anesthesia, and these routine procedures were not changed for the study. Our results are in accordance with data from a retrospective analysis (18) showing no significant difference in length of stay in the recovery room among patients after total hip or knee replacement performed with general, epidural, or spinal anesthesia (a mean of two to three hours in all groups). As to the length of the hospital stay, several attempts have failed to demonstrate significant differences between IV PCA and EDA (19), despite the fact that regional anesthesia seems to reduce surgical morbidity (20,21).
Our results indicate that patients in the EDA group are in a stable and comfortable condition much sooner after operation than patients in the GA/PCA group. Nevertheless, improvement of pain management does not automatically result in improvement in other outcome variables (22). This is mainly because hospital routines do not take advantage of the improved pain management. Early mobilization, early enteral feeding, etc. have been proposed as additional components of a multimodal approach to control postoperative pathophysiology and to enhance rehabilitation (23–25).
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Acknowledgments
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This study was supported by Astra Pain Control.
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Footnotes
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1 Center 1: H. Wulf, MD, J. Quitmann, MD, A. Kern: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Kiel, Kiel, Germany. Center 2: J. Motsch, MD; C. D. Serf, MD; A. Klinke, MD: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Heidelberg, Heidelberg, Germany. Center 3: J. Biscoping, MD, R. Fischer, MD, B. Merkle, MD: Department of Anesthesiology and Intensive Care Medicine, St. Vincentius Hospital, Karlsruhe, Germany. Center 4: H. Van Aken, MD, Th. Prien, MD, B. Beland, MD: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Münster, Münster, Germany. Center 5: B. Bachmann-Mennenga, MD, G. Veit, MD: Department of Anesthesiology and Intensive Care Medicine, Hospital of Minden, Minden, Germany. Astra Pain Control: B. Hägglöf, PhD, A. Kristoffersson, PhD, O. Guilbaud, PhD: Department of Clinical Research and Development, Astra Pain Control, Södertälje, Sweden. H. Bauer, W. Meyer-Sabellek, MD: Astra GmbH, Wedel, Germany. 
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Accepted for publication April 2, 1999.
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Abstract
Introduction
