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Ann Thorac Surg 1998;66:367-372
© 1998 The Society of Thoracic Surgeons

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Original articles: general thoracic

Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain

^a Department of Surgery, University Hospital, Zürich, Switzerland
^b Institute for Anesthesiology, University Hospital, Zürich, Switzerland

Accepted for publication March 23, 1998.

Address reprint requests to Dr Weder, Departement Chirurgie, Klinik für Viszeralchirurgie, Universitätsspital, Rämistr. 100, CH-8091 Zürich, Switzerland

	Abstract

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Background. Thoracic epidural analgesia is considered the method of choice for postthoracotomy analgesia, but it is not suitable for every patient and is associated with some risks and side effects. We therefore evaluated the effects of an extrapleural intercostal analgesia as an alternative to thoracic epidural analgesia.

Methods. In a prospective, randomized study, pain control, recovery of ventilatory function, and pulmonary complications were analyzed in patients undergoing elective lobectomy or bilobectomy. Two groups of 15 patients each were compared: one received a continuous extrapleural intercostal nerve blockade (T3 through T6) with bupivacaine through an indwelling catheter, the other was administered a combination of local anesthetics (bupivacaine) and opioid analgesics (fentanyl) through a thoracic epidural catheter.

Results. Both techniques were safe and highly effective in terms of pain relief and recovery of postoperative pulmonary function. However, minor differences were observed that, together with practical benefits, would favor extrapleural intercostal analgesia.

Conclusions. These results led us to suggest that extrapleural intercostal analgesia might be a valuable alternative to thoracic epidural analgesia for pain control after thoracotomy and should particularly be considered in patients who do not qualify for thoracic epidural analgesia.

	Introduction

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Pain is considered a major independent factor responsible for postoperative morbidity and mortality after thoracic operations. Because pain functionally results in lung restriction, adequate ventilation and coughing are compromised. Airway secretions are not sufficiently cleared and may thus form endobronchial plugs. Such bronchial obstructions either result in subsequent atelectasis or, even worse, if followed by bacterial colonization, initiate parenchymal lung infection. Systemic and potentially life-threatening problems such as sepsis, increased intrapulmonary shunting, hypoxemia, and cardiac failure may develop. If the underlying airway obstruction is reversed, however, complications may be mild and of a transient and limited nature.

Various methods for pain management after thoracic surgery are currently used [1–3]. Systemic use of narcotics or nonsteroidal antiinflammatory drugs, administered either alone or in combination, often do not result in satisfactory pain relief [4]. Furthermore, serious adverse effects may occur at higher doses. For example, opioid analgesics are associated with respiratory depression, nausea, and bowel dysfunction, whereas the often quoted risk of addiction is negligible in acute pain treatment. Nonsteroidal antiinflammatory drugs, on the other hand, may cause gastrointestinal problems (bleeding, dyspepsia), acute renal failure, or platelet dysfunction [4]. Optimized strategies therefore aim at improving pain relief by selective and locally concentrated administration of drugs to the pain-causing anatomic region rather than by systemic saturation with analgesics [3]. Such regional analgesia guarantees excellent pain control when administered through an epidural catheter [5, 6]. It has therefore proved to be a gold standard method for pain control after thoracic operations [7]. Epidural anesthesia, however, is not suitable for all patients and carries potential risks and limitations such as dural perforation, bleeding, infection, hypotension, and bradycardia, as well as urinary retention [5, 6, 8]. Furthermore, immediate or delayed respiratory depression may occur when opioid narcotics are administered epidurally [9–11]. Last but not least, numerous patients are not candidates for epidural analgesia for anatomic reasons or because they refuse it.

Continuous intercostal neuronal blockade has been reported to be very effective [12–14] and might be an alternative to thoracic epidural analgesia (TEA). In this article, we report the results of a prospective randomized clinical study that was designed to compare continuous extrapleural analgesia (XPA) with continuous TEA in patients undergoing elective thoracic operations. In the XPA group, a continuous intercostal nerve block resulted from local anesthetics that were continuously infused through a catheter placed in the extrapleural space as the last step of the operation. The TEA group received local anesthetics—supplemented with a small dose of opioid analgesics to avoid tachyphylaxis—through a thoracic epidural catheter inserted preoperatively before the induction of general anesthesia.

	Material and methods

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Patient selection and randomization
After institutional approval, the following protocol was carried out. During a 1-year period, patients undergoing elective anterolateral thoracotomy (fourth intercostal space) for lobectomy or bilobectomy without pleural resection were randomly assigned to receive either TEA or intercostal XPA for postoperative pain management. Excluded were (1) patients undergoing lobectomy or bilobectomy in combination with resection of the pleura, (2) patients with a history of severe heart disease (New York Heart Association class more than II) or hepatic or renal insufficiency (as determined by preoperative blood tests), (3) patients with hemorrhagic diathesis or a medication of anticoagulants or acetylsalicylic acid within the last 10 days before admission, and (4) patients with a known allergy to local anesthetics or with another contraindication to epidural techniques. Informed consent was obtained from every participating patient.

Baseline analgesia and installation of extrapleural and thoracic epidural analgesia
Patients of either group received a baseline analgesic medication with nonsteroidal antiinflammatory drugs (meflumenaminic acid, 500 mg every 6 hours) and were allowed to ask for supplemental subcutaneous opiate injections (nicomorphine; maximal dose, 0.1 mg/kg every 4 to 6 hours) if required.

Individuals assigned to the XPA group received a catheter at the end of the surgical procedure, just before chest closure. The parietal pleura was freed between the dorsal end of the thoracic incision and the costovertebral junction. A rigid 5F polyethylene catheter (William Cook Europe A/S, Bjaeverskov, Denmark) with 20 terminal sideports was placed extrapleurally in a dorsal paravertebral position perpendicular to three to four intercostal spaces (T-3 through T-8). The pleural incisions were carefully closed to prevent intrapleural losses of the perfusate. Intercostal nerve anesthesia was initiated intraoperatively with infusion of 20 mL bupivacaine 0.5% during a 20-minute period. A continuous perfusion (0.1 mL · kg^-1 · h^-1) with 0.5% bupivacaine supplemented with 0.05 U/mL of ornipressin (POR-8; Sandoz, Basel, Switzerland) was maintained for a minimum of 5 days, irrespective of the patient’s location (intensive care unit [ICU] or surgical ward).

In patients assigned to the TEA group, a catheter was placed into the epidural space at a thoracic level (between T-5 and T-6) before the induction of general anesthesia. A continuous infusion (4 to 6 mL/h) of 0.5% bupivacaine was administered during the operation; maintenance therapy after termination of the operation was achieved by means of a continuous infusion of 4 to 8 mL/h of 0.25% to 0.375% bupivacaine that was supplemented with 2 µg/mL fentanyl to prevent tachyphylaxis.

All patients were postoperatively taken to the ICU for a minimum of 2 days, and remained there until they presented themselves in stable cardiopulmonary condition based on criteria not related to this study. Although the risk for respiratory depression or hypotension is statistically low (<1%), the local hospital policy limited, for safety considerations, the administration of epidural anesthesia to the availability of ICU monitoring. When patients were able to be transferred to the surgical ward, TEA was therefore stopped and the catheter removed before relocation of the patients. Pain control was subsequently achieved by means of nicomorphine injections as described above.

Measurements
Pain was assessed by the patients themselves four times per day on a simplified visual analogue scale with scores ranging from zero to four: 0 = no pain; 1 = little pain; 2 = moderate pain; 3 = severe pain; and 4 = intolerable pain. In addition, the daily consumption of opioid analgesics was documented.

Daily at noon, forced vital capacity (FVC) and forced expiratory volume within 1 second (FEV₁) were measured by means of a portable spirometer (Micro-Spirometer; Micro Medical Ltd, Kent, UK), with the patient taking a sitting position. The best of three consecutive measurements was used for data analysis.

Serum levels of bupivacaine were measured in both groups on day 1, ie, 24 hours after catheter placement. In addition, they were assessed on day 3 in patients with extended use of XPA to monitor the individual degree of bupivacaine accumulation during the period of observation.

Analysis of data
Statistical analysis of parametric data was accomplished using the unpaired Student’s t test for comparison of the two groups, and one-way analysis of variance for repeated measurements and the Student-Newman-Keul test as a post-hoc test were used for comparison of repeated data within each group. For nonparametric data (pain scores) the Mann-Whitney rank sum test was used to compare the two groups, and the Friedman analysis of variance on ranks was used for repeated measurements within each group. Data reported in this article and shown in the figures represent means ± standard error of the mean. Differences in the observed results were considered significant when p was less than 0.05.

	Results

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
General aspects
Thirty patients fulfilled the study criteria and could therefore be included in the trial. The characteristics of these patients are shown in Table 1. The two study groups did not differ in terms of the type and duration of the operative procedure or the preoperative respiratory function. The implantation of the XPA catheter was simple, took less than 10 minutes, and did not cause any local problems. Positioning of the TEA catheter was accomplished preoperatively. Complications caused by the implantation of either catheter type were negligible. Unintentional dural puncture with subsequent liquor loss syndrome occurred in one patient receiving TEA. Other known complications such as local hematomas, infections, or catheter obstructions did not occur in our study population. Effective epidural analgesia ideally resulted in a segmental anesthesia without motoneuron involvement. In some patients, however, variable extents of motor or sympathetic blockade were observed but not specifically documented in the present study. Extrapleural analgesia, on the other hand, resulted in a segmental unilateral analgesia and a dermal hypesthesia. Two patients of either group had to be excluded from data analysis because the respective catheters proved ineffective because of malpositioning or secondary displacement as a result of insufficient fixation. After exclusion from the study, effective pain relief in all 4 patients was achieved by means of an epidural catheter insertion or replacement. Patients of either group were considered stable and transferrable after 2.7 ± 0.2 days (no difference between the two groups). As indicated above, TEA was removed at that moment but patients were transferred from the ICU only after 3.4 ± 0.4 days. Patients with XPA, on the other hand, were transferred to the surgical ward after 2.7 ± 0.2 days although the use of XPA was extended and maintained for 6.6 ± 0.5 days. No catheter- or drug-related problems were recorded in the period of extended XPA use.

View larger version (19K): [in this window] [in a new window]   Fig 1. Time courses of forced vital capacity (A) and forced expiratory volume in 1 second (FEV1) (B), expressed as percentages of the preoperative values. Data points represent the mean and the vertical error bars the ± standard error of the mean. The extended period of observation after discontinuation of thoracic epidural analgesia (TEA, see text) is indicated by a break in the x-axis. Overall recovery of the respiratory function was comparable in both groups, but on the second postoperative day, function tests were significantly better in the extrapleural intercostal analgesia (XPA) group. (*p < 0.05 when time points of either group [n = 13] were compared by Student’s t test.)

View larger version (23K): [in this window] [in a new window]   Fig 2. Time course of postoperative visual analogue pain scores: 0 = no pain; 1 = little pain; 2 = moderate pain; 3 = severe pain; 4 = intolerable pain. Data points represent the mean and the vertical error bars the ± standard error of the mean. The extended period of observation after discontinuation of (TEA, thoracic epidural analgesia; see text) is indicated by a break in the x-axis. Except for the day of the operation and the first postoperative day, pain scores were lower in the extrapleural intercostal analgesia (XPA>) group (see text). *p < 0.05 when both groups [n = 13] were compared by Mann-Whitney rank sum test.

View larger version (25K): [in this window] [in a new window]   Fig 3. Time course of daily supplementary opiate (nicomorphine) consumption. Data points represent the mean and the vertical error bars ± the standard error of the mean. The extended period of observation after discontinuation of thoracic epidural analgesia (TEA, see text) is indicated by a break in the x-axis. Opiate consumption was lower in the extrapleural intercostal analgesia (XPA) group on postoperative day 2. (*p < 0.05 when both respective time points of either group [n = 13] were compared by Student’s t test.)

Severe complications
Severe complications were rare (Table 1). Postoperative atelectasis or pneumonia developed in two patients in whom pain control was achieved by means of TEA. In 1 patient, pneumonia subsequently resulted in a septic syndrome with multiorgan failure and led to the patient’s death. No systemic complications were recorded in the XPA group. The low incidence of complications, however, does not allow statistical comparison of the two groups.

	Comment

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Adequate pain control may be considered an integral part of patient management after thoracic surgical procedures [7]. Thoracic epidural analgesia combining local anesthetics and opioid analgesics has been shown to be highly effective for the control of postoperative pain after thoracic operations [6, 8]. It may thus currently be considered the gold standard method with which other modalities should be compared. Despite the seemingly straightforward character of this technique, the catheter insertion requires considerable experience [15] and may in some patients even be technically impossible (eg, for anatomic reasons or after spinal operations). Potential complications such as dural puncture, bleeding, hematoma, and infection at the catheter implantation site need to be taken into consideration [8]. Furthermore, patients suffering from a coagulation disorder—including drug-induced disorders, eg, those resulting from drugs such as acetylsalicylic acid with a platelet-inhibitory effect—may be at a higher risk or may not be suitable for TEA. Although the danger of a delayed respiratory depression is small after the administration of epidural opioids [9–11], it may result in serious complications or even fatal outcome. There are a number of side effects, such as urinary retention, hypotension and bradycardia, opioid-induced pruritus, and motor neuron involvement with paraparesis of the lower extremities or weakness of the upper extremities, which are uncomfortable rather than dangerous [16, 17].

Intercostal nerve blockade—a potential alternative—has recently moved into the center of interest and should be systematically analyzed. Attempts at obtaining satisfactory pain relief by means of diffuse infusions of local anesthetics into the pleural space (intrapleural analgesia), however, have provided conflicting results [18–21]. Selective blockade of the intercostal nerves at the level of the surgical incision, on the other hand, has been shown to effectively lessen pain sensations, be it by means of serial injections, cryoanalgesia, or a continuous intercostal infusion [12–14, 22–25]. The first two modes of intercostal blocks are either uncomfortable for the patient of have been associated with long-term intercostal neuralgia [2, 26]. These disadvantages are avoided when intercostal blockade is achieved by means of an indwelling catheter that is positioned in the extrapleural space during the operation and under visual control. An increasing number of reports have demonstrated a benefit from this technique as opposed to the administration of parenteral opioids; however, there are few studies comparing a continuous intercostal blockade with an epidural anesthesia. In one study, administration of lumbar epidural morphine was assessed and found to be less effective than a continuous intercostal blockade [27]. Another study, comparing a continuous extradural infusion at a thoracic level, a continuous paravertebral (extrapleural) block, and a single intrathoracic block, was not able to demonstrate any difference [28], but because the study included patients with a variety of different surgical procedures, large interindividual variations were found.

Our study therefore aimed at further elucidating that specific question in a more homogeneous group of patients submitted to lobectomy or bilobectomy but no other procedures. The primary focus of observation was the early postoperative period after thoracotomy ranging from the day of surgery until the second postoperative day. Both TEA and XPA were maintained at least for that period allowing for an unbiased comparison of the two groups. After that moment, ie, when TEA was removed (after 2.7 ± 0.2 days) whereas XPA was continued (for 6.6 ± 0.5 days), both groups in a strict sense were not comparable anymore. Nonetheless, we extended our observation to a total of 5 days to compare the two methods within the context of two balanced pain control regimens: TEA in one and XPA in the other group. The reason to do that was the fact that many hospitals around the world (like our institution) still require ICU monitoring for patients with TEA although some others do not. These restrictions and the fact that TEA is not suitable for every patient make the search for alternative treatment strategies a necessity for better patient care.

In our study, a dual approach (ie, visual analog scale scores and respiratory function tests) was used to substantiate the effect of the two regimens. These two parameters have been found to correlate fairly well with each other. Yet, functional parameters, which indirectly indicate the presence of pain, should be used with caution. This is especially necessary because thoracic operations as such and in combination with a surgical reduction of lung parenchyma may result in a substantial decrease in vital capacity and functional residual capacity.

Despite the fact that we were unable with either method to reach the previously reported high success rates [29], our results indicate that both of the tested regimens (TEA and XPA) displayed similar effects. Postoperative pain control was within a comparable range albeit not at all time points. Immediately after the operation, the maximal pain scores were higher in the XPA group that in the TEA group, a finding that contrasts with the subsequent course. This variation may be attributed to inevitable setup differences between the two study groups. Whereas TEA was installed and initiated before or during the operation, XPA was started shortly before completion of the operation. Hence, the interval between chest closure and the patients’ arousal might have been too short for the anesthetic agent to diffuse from the catheter to the intercostal and paravertebral spaces, which play a major role for the pain-relieving effect of XPA [30]. If the difference between XPA and TEA on the day of surgical procedure was solely caused by pharmacokinetic factors, it could be expected to disappear on initiation of XPA at the beginning rather than at the end of the procedure. However, alternative interpretations should consider the concept of preemptive analgesia. Providing analgesia and anesthesia before initiating the pain-causing action has been reported to reduce pain sensitization within the central nervous system. In addition to lower pain scores in the postoperative arousal period, preoperative TEA may thus have contributed to a more balanced and superficial anesthesia throughout the procedure, but that issue has not been addressed in our study.

After the first day, faster recovery and lower pain scores were observed in the XPA group, being most divergent on the second and third postoperative day. The peak consumption of opioid analgesics shifted from the first day (in the XPA group) to the second day (in the TEA group). This finding has, in part, to be seen in the context of TEA discontinuation between the second and third days. It also should be noted, though, that this interpretation does not explain the findings up to the second postoperative day. Patients of the TEA group, for example, started with lower respiratory function tests and consumed more opioid analgesics on the first postoperative day although both groups displayed identical pain scores at their particular moment.

By and large, serious local or systemic complications were rare with either technique. Neither systemic accumulation nor toxicity of bupivacaine occurred in our patient collective, although a higher concentration of the agent was used for XPA (0.5%) than for TEA (0.25% to 0.375%). Addition of ornipressin (POR-8) to the XPA infusion most likely prevented the systemic resorption of bupivacaine and contributed to a prolonged local effect. Both methods (TEA and XPA) had the same failure rate and were equally safe. In our experience, XPA could easily be managed on the surgical ward without handling problems. Patients could benefit from the extended administration of regional anesthesia without being restricted by adverse effects such as limited mobilization or urinary retention. After a preliminary stop of the XPA infusion, some patients favored a continuation of XPA for up to 6.6 ± 0.5 days although the extended study end point was the fifth postoperative day. Another possible benefit of XPA may be a financial one. A shorter stay in the ICU could result in lower costs. However, the cost-effectiveness of the two methods was not analyzed in the present study (eg, total length of hospital stay, material costs).

Despite the fact that some of the observed differences between the two regimens were statistically significant in favor of XPA, our study indicates that TEA and continuous XPA are equipotent and safe methods for postoperative pain control after elective lung operation, and may also contribute to the prevention of respiratory complications. We therefore believe that XPA should be the method of choice in patients who either do not qualify for TEA or refuse it. Furthermore we suggest that XPA should seriously be considered a valuable alternative to TEA in all other patients. Larger patient series will be necessary to compare the two methods with regard to the incidence of serious complications.

	Acknowledgments

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We are indebted to Petra Lott for her help in preparing the manuscript.

	References

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 

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