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© 1999 International Anesthesia Research Society
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Abstract |
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The aim of this prospective, randomized, double-blinded study was to compare pain relief, side effects, and ability to ambulate during epidural anesthesia with ropivacaine 0.2% plus sufentanil versus bupivacaine 0.175% plus sufentanil after major gastrointestinal surgery. Epidural catheters were inserted at T8–11, and 30 µg of sufentanil with 15 mL of ropivacaine 0.75% (Group 1, n = 42) or bupivacaine 0.5% (Group 2, n = 44) was injected. General anesthesia was induced, a continuous epidural infusion (5 mL/h) was then begun with 1 µg/mL sufentanil plus ropivacaine 0.2% (Group 1) or bupivacaine 0.175% (Group 2). Postoperatively, the infusion rate was adjusted to individual requirements. Patients were also able to receive additional 2-mL bolus doses every 20 min. Demographic data (except for gender and height), analgesia, drug dosage, and side-effects, including motor blockade (Bromage score), were similar in both groups, but mobilization recovered more quickly in Group 1. Gender, age, ASA physical status, duration of surgery, and intraoperative blood loss had no effect on mobilization. We conclude that epidural analgesia is effective and safe with both regimens. There is not necessarily a correlation between the Bromage score and the desired outcome of mobilization. The ability to walk postoperatively is hastened if ropivacaine is used instead of bupivacaine.
Implications: Regarding pain relief and side effects, epidural analgesia with ropivacaine 0.2% and sufentanil 1 µg/mL yields pain scores and pain intensity comparable to those for the well evaluated combination of bupivacaine 0.175% and sufentanil 1 µg/mL. However, earlier recovery of the ability to walk unassisted in patients receiving the combination of ropivacaine and sufentanil may result in their earlier rehabilitation.
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Introduction |
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Two principles have been established in postoperative epidural analgesia to optimize analgesia and reduce the side effects of local anesthetics (1). First, epidural drugs should be delivered to the affected dermatomes. Catheters are inserted at the center of the spinal segments involved in the transmission of nociceptive stimuli from the peripheral neuron to the spinal neuron. Lumbar epidurals are used for lower-extremity surgery and thoracic epidurals for abdominal or thoracic operations (2). Second, different classes of analgesics should be combined. This results in effective pain relief as a result of synergistic or additive analgesic action, with a reduced incidence of side effects. It has been demonstrated that coadministering epidural sufentanil 1 µg/mL and bupivacaine 0.175% improves the quality of analgesia and reduces the required drug dosage in comparison with bupivacaine (3).
Ropivacaine presumably produces less central nervous toxicity and cardiac toxicity than bupivacaine (4,5). Pharmacodynamic studies have found that ropivacaine blocks C fibers faster than A fibers and produces a frequency-dependent block. Blockade of A fibers was less with ropivacaine than with similar concentrations of bupivacaine, whereas the degree of C-fiber block was similar with both drugs (6,7). This differential blocking effect of ropivacaine provides analgesia with less motor block than comparable concentrations of bupivacaine (8,9). Postoperative pain during activity is effectively controlled if ropivacaine is administered at a concentration of 0.3%. However, to achieve a lower incidence of motor blockade, a lower concentration (0.2%) with less analgesic strength has been selected as optimal for postoperative analgesia (10). Combining this concentration of ropivacaine with sufentanil may increase postoperative pain relief. Ropivacaine 0.2% may therefore be more suitable than bupivacaine 0.175% for the epidural combination of a local anesthetic with sufentanil.
This prospective, double-blinded, randomized study was designed to test the hypothesis that a combination of small-dose sufentanil 1 µg/mL and ropivacaine 0.2% instead of bupivacaine 0.175% achieves similar analgetic quality and has a similar safety profile but allows earlier recovery of postoperative mobilization.
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Methods |
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A total of 100 patients were randomized to receive either a combination of ropivacaine 0.2% and sufentanil 1 µg/mL (Group 1) or bupivacaine 0.175% and sufentanil 1 µg/mL (Group 2) for postoperative analgesia after major gastrointestinal surgery. We obtained approval from our local ethics committee, and written, informed consent was obtained from all subjects. Except for the pharmacist, all participants (investigators, other staff, and patients) were blinded to the drug administered epidurally.
Epidural thoracic catheters for intraoperative and postoperative pain control were inserted at T8–11 before the induction of general anesthesia. An initial dose of either 15 mL of ropivacaine 0.75% with 30 µg of sufentanil (Group 1) or 15 mL of bupivacaine 0.5% with 30 µg of sufentanil (Group 2) was applied epidurally to establish a sensory block up to T4, and the block was confirmed before the introduction of general anesthesia. There was no failure of blockade at this point. General anesthesia was induced by IV thiopental (5 mg/kg) and sufentanil (0.3–0.5 µg/kg). Pancuronium bromide (0.1 mg/kg) was administered to facilitate tracheal intubation. Lungs were mechanically ventilated with PETCO2 maintained at 35–45 mm Hg. Maintenance of anesthesia was achieved by continuous administration of 0.6%–0.8% inspiratory isoflurane and 60% nitrous oxide in oxygen in a semiclosed circuit, with intermittent positive pressure ventilation. An infusion (5 mL/h) was started before the surgical incision, providing a continuous mixture of ropivacaine 0.2% and 1 µg/mL sufentanil (Group 1) or of bupivacaine 0.175% and 1 µg/mL sufentanil (Group 2) epidurally. Postoperatively, the rate of the epidural infusion was adjusted to individual patient requirements by the acute pain service team. Patients were instructed to self-administer additional epidural bolus doses on demand through the same pump (2-mL dose, 20-min lockout interval) to achieve a pain score <4 during rest and a dynamic pain score (i.e., the score for pain during movement, coughing, or taking deep breaths) <6 on a visual analog scale (VAS) of 0–10 (0 = "no pain" and 10 = "the worst pain possible"). Twice a day, members of the acute pain service adjusted the infusion rate to patient individual needs and treated any side effects and complications. After 3 days, the infusion rate was reduced in steps of 2 mL/h until it was completely stopped, and the catheters were withdrawn in the evening of the fourth or on the fifth postoperative day if the patients were free of pain using a combination of IV propacetamol and tramadol. If the patients were still suffering pain, the epidural analgesia was reinstated for 1 day, after which weaning was restarted.
To avoid confounding effects, all the data for the study were recorded by an independent investigator who visited the patients during the evening outside the period of the postoperative pain service rounds. Drug dosage, quality of analgesia, and side effects of local anesthetics and opioids were recorded once a day during the 3 days before the reduction of the epidural infusion rate. Drug dosage was assessed according to the daily cumulative volume of epidural infusion administered. The quality of analgesia during rest and during movement was observed using the VAS scores.
Information on the following side effects was noted: lower extremity motor block [Bromage score (11): normal motor function = 0; impaired motor function >0], respiratory depression (normal rate = 1, 8–12 breaths/min = 2, <8 breaths/min = 3), sedation (1 = awake, 2 = tired, 3 = asleep but can easily be woken, 4 = coma), pruritus (yes or no), nausea (yes or no), emesis (yes or no).
Postoperative mobilization was assessed for 4 postoperative days on a four-point scale: 1 = lying in bed, 2 = able to sit outside the bed, 3 = able to move outside the bed for a limited time (with accompanying person; <30 min), 4 = able to move without limits.
Statistical analyses were performed using the SPSS system (SPSS Inc., Chicago, IL). Normal scale variables were described by relative and absolute frequencies, and differences between groups were assessed by using the 
2 test. Fisher's exact test was used if matched cells were rare (frequency <5). Variables with interval or higher-scale levels were described as means and standard deviation. A t-test for independent variables or a repeated-measures analysis of variance was used to compare Groups 1 and 2.
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Results |
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A total of 14 patients were excluded from the statistical analyses because of protocol violation (dislocation of epidural catheter during the postoperative observation period). The results are therefore based on 42 patients in Group 1 and 44 patients in Group 2. Except for gender (P = 0.00) and height (P = 0.02), there were no significant differences between the groups in the demographic data, preoperative diagnoses, and intraoperative characteristics (Tables 1 and 2).
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The drug dose and quality of analgesia did not differ between the two groups. The cumulative volumes of the epidural drugs were similar in all patients (Fig. 1). Dynamic pain was maximal on the first and second postoperative days and decreased 3 days after surgery (Fig. 1
). Nausea or vomiting was rare, and there was no significant difference between the groups. None of the patients suffered from respiratory depression or severe sedation (Table 3). There was no significant statistical effect of the type of local anesthetic used on motor blockade, but a Bromage score >0—indicating reduced motor function in the lower extremities—was observed only in patients receiving bupivacaine. In addition, postoperative mobilization was restored earlier in the patients receiving epidural ropivacaine. On the first postoperative day, 80% of the patients in Group 1 and 59.1% of Group 2 patients were able to walk for a limited time (P < 0.05). On the third postoperative day, 80% of Group 1 patients (Group 2: 52.3%; P < 0.05) were able to walk for an unlimited period (Fig. 2). This number increased to 95% of the patients in Group 1 on the fourth postoperative day (Group 2: 79.5; P < .05).
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To evaluate whether recovery of ambulation was influenced by the gender inequality, the mobilization scores of men and women within each group were compared by using the Mann-Whitney U-test and Fisher's exact test. Significant differences between the genders could not be demonstrated.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Epidural analgesia is one of the most effective regimens for postoperative pain relief (12). Given the risks of this technique (13,14), such as spinal cord compression, extended motor blockade should be avoided. For this reason, low concentrations of bupivacaine 0.175% or ropivacaine 0.2% are continuously infused intraoperatively after administering an initial dose to achieve an epidural block up to T4.
Relief of pain is not the only purpose of postoperative epidural analgesia. Another important goal of this procedure is to improve outcome after surgery. Of course, postoperative outcome is a complex entity that is affected by a great variety of influencing factors. Blocking the afferent neural stimulus by epidural technique is very effective in reducing the classical hormonal and metabolic stress response to surgery, especially with the use of continuous analgesia with extradural local anesthetics (15–17). Postoperative epidural analgesia is therefore combined with other forms of postoperative treatment: early tracheal extubation, early forced mobilization, and early oral nutrition to optimize postoperative recovery (15,16). However, the beneficial effects attributed to this multimodal regimen require careful surveillance to control the side effects of epidural local anesthetics, particularly motor blockade.
The combination with opioids reduces drug dose and thus may reduce the side effects of local anesthetics. Coadministration of small-dose bupivacaine and sufentanil at a thoracic level results in good analgesia and a low rate of side effects of both drugs (3,19).
The combination of epidural ropivacaine 0.2% and sufentanil 1 µg/mL provides excellent postoperative analgesia, which is comparable to that of the well evaluated combination of bupivacaine 0.175% and sufentanil 1 µg/mL. The rate of side effects was comparable in the two groups. No patient suffered from respiratory depression or severe sedation. Thus, the risk of side effects of the opioid sufentanil is not increased if ropivacaine is used instead of bupivacaine. Both regimens are safe to use on normal hospital wards if they are supervized by a postoperative pain service and if risk factors of respiratory depression are considered. In a prospective study, 2022 postoperative patients receiving combined epidural sufentanil and bupivacaine were treated by a postoperative pain service team without respiratory depression (20).
Thus, with respect to opioid side effects, there is no difference between the combination of sufentanil with bupivacaine or ropivacaine. However, considering local anesthetic toxicity, ropivacaine may be superior (4). None of the patients in our study receiving ropivacaine suffered from motor impairment from the first postoperative day onward. In Group 2, motor blockade was observed in three patients on the first postoperative day and in two patients on the second and third postoperative days. In view of the inadequate analgesic effects of monotherapy with ropivacaine 0.2% and the increased incidence of motor block, if a rapid infusion rate or a higher concentration of 0.3% is used (10,21), coadministering sufentanil 1 µg/mL with ropivacaine 0.2% seems to offer an optimal regimen in postoperative epidural analgesia. This regimen is superior to single drug use.
Etches et al. (21) studied the effects of different infusion rates of ropivacaine 0.2%. They observed that the number of patients with a Bromage score of 0 or 1 was higher than the number of patients who were able stand beside their beds. This illustrates that the ability to stand or walk requires a more complex recovery of sensory and motor function than is evaluated using the Bromage score alone. As the mobilization score in the present study showed, patients in Group 1 recovered earlier than those in Group 2. Further analyses of other important variables influencing postoperative mobilization, such as age, ASA physical status, duration of surgery, or intraoperative blood loss, did not reveal statistical significance. Gender inequality also does not explain the differences in recovery of ambulation. A confounding statistical effect of the unequal distribution of male and female patients in both groups could not be demonstrated, and there were no specific gynecological procedures included in the study: all patients underwent gastrointestinal surgery.
Thus, early recovery of the ability to walk may be improved if sufentanil is combined with ropivacaine 0.2% instead of bupivacaine 0.175%.
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References |
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- Steinbrook RA. Epidural anesthesia and gastrointestinal motility. Anesth Analg 1998;86:837–44.[Web of Science][Medline]
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[Abstract/Free Full Text] - Zaric D, Nydahl PA, Philipson L, et al. The effect of continuous lumbar epidural infusion of ropivacaine (0.1%, 0.2%, and 0.3%) and 0.25% bupivacaine on sensory and motor block in volunteers a double-blind study. Reg Anesth 1996;21:14–5.[Web of Science][Medline]
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