BJA Advance Access originally published online on February 13, 2006
British Journal of Anaesthesia 2006 96(4):492-496; doi:10.1093/bja/ael025
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Patient-controlled cervical epidural fentanyl compared with patient-controlled i.v. fentanyl for pain after pharyngolaryngeal surgery
1Département d'Anesthésie-Réanimation, Hôpital Bellevue, Centre Hospitalier et Universitaire de Saint Etienne 42055 Saint Etienne Cédex 2, France
2Service d'OtoRhinoLaryngologie, Hôpital Bellevue, Centre Hospitalier et Universitaire de Saint Etienne 42055 Saint Etienne Cédex 2, France
*Corresponding author. Email: marc.roussier{at}chu-st-etienne.fr
Accepted for publication November 6, 2005.
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Abstract |
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Background. Analgesia after pharyngolaryngeal surgery is commonly provided through the i.v. route. The aim of the study was to compare cervical epidural administration of fentanyl with the i.v. route for postoperative analgesia after pharyngolaryngeal surgery.
Methods. In a randomized double-blind study 42 patients received fentanyl via patient-controlled analgesia (PCA) either through the i.v. route (PCA-IV group, n=22) or through the cervical epidural route (PCA-Epid group, n=20). Identical PCA settings were used in the two groups (bolus dose: 1.5 µg kg–1, bolus: 25 µg, lockout interval: 10 min, maximum cumulative dose: 400 µg per 4 h). Analgesia at rest and during swallowing was evaluated using a visual analogue scale.
Results. Analgesia at rest was better in the PCA-Epid group than in the PCA-IV group but only 2 and 6 h after surgery (P<0.02). There was no difference in analgesia during swallowing. Cumulative doses of fentanyl were similar {PCA-Epid group: 1412 µg (912), PCA-IV group: 1287 µg (1200) [median (IQR)]}. The PaO2 showed a significant decrease between the preoperative and postoperative period, but this decrease was identical in the two groups [PCA-IV-group: 11.47 (2.4) kPa vs 8.27 (0.9) kPa; PCA-Epid group: 11.33 (1.9) kPa vs 9.20 (2.4) kPa for preoperative and postoperative period respectively].
Conclusions. The study results show that cervical epidural analgesia provides marginally better pain relief at rest with no decrease in the fentanyl consumption. The use of the cervical epidural administration of fentanyl is questionable because of the possible complications of the technique.
Keywords: anaesthetic techniques, epidural; analgesia, patient-controlled; analgesia, postoperative; analgesics opioid, fentanyl; surgery, otolaryngological
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Introduction |
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Pharyngolaryngeal cancer surgery is associated with a high level of pain in the postoperative period. Although the superiority of the epidural route for postoperative analgesia has been shown in patients undergoing a variety of surgical procedures,1 analgesia for pharyngolaryngeal surgery is commonly provided through the i.v. route. Cervical epidural anaesthesia with local anaesthetics in combination with general anaesthesia has been reported in head and neck surgery.2 3 However, in the postoperative period, cervical epidural administration of local anaesthetics causes hypotension and reduced pulmonary function.4 5 Epidural opioid administration for postoperative analgesia has been described at both lumbar and thoracic levels. Fentanyl is frequently preferred to other analgesics because of its high lipid solubility resulting in rapid onset of analgesia, a low incidence of side-effects and a low risk of delayed respiratory depression.6 Results are conflicting concerning the efficacy of epidural compared with i.v. fentanyl. Some studies report equivalent analgesia,7–11 others report better analgesia with the epidural route.12 13 To date, no published data have compared i.v. opioid analgesia with cervical epidural opioid analgesia after pharyngolaryngeal surgery. Thus, a prospective, double-blind randomized placebo-controlled study was designed to compare the efficacy and side-effects of patient-controlled analgesia (PCA) with i.v. fentanyl with PCA fentanyl via cervical epidural after pharyngolaryngeal cancer surgery.
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Methods |
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The study was approved by the local Human Investigation Committee. After informed written consent, 46 patients undergoing elective laryngeal surgery for cancer with tracheotomy were enrolled. Exclusion criteria included a history of chronic pain or opioid dependence, contraindications to cervical epidural catheter placement (coagulation defects, patient refusal), inability to understand PCA, chronic respiratory impairment, ASA status IV or V and age less than 18 yr. All surgery was performed by the same surgeon.
The day before surgery, all patients were familiarized with a PCA device and a standard visual analogue scale (VAS) for pain (0=‘no pain’, 10=‘worst pain imaginable’).
Before premedication, arterial blood gases were measured. The patients were given hydroxyzine 1.5 mg kg–1 orally as premedication. Immediately before surgery, a cervical epidural catheter was inserted at the C7–T1 space and correct placement was confirmed by administration of a test dose of lidocaine 2% 3 ml with 1:200 000 epinephrine. The patients were positioned in the Trendelenburg position (15°) and they then received lidocaine 1% 5 ml with 1:200 000 epinephrine and bupivacaine 0.25% 5 ml through the epidural catheter. Anaesthesia was induced i.v. with midazolam 0.05 mg kg–1 and propofol 2.5 mg kg–1. The trachea was intubated after local anaesthesia of the glottis with lidocaine 5% spray and mechanical ventilation of the lungs was instituted. Anaesthesia was maintained with oxygen (50%), nitrous oxide (50%) and isoflurane 1–1.5%. Further epidural doses of bupivacaine 0.25% 5 ml were given every 90 min. No i.v. analgesics or neuromuscular blocking agents were used.
In the recovery room, when patients were awake enough to follow instructions, the use of the PCA device and VAS was explained again. Patients were then allocated randomly into PCA-IV and PCA-Epid groups by the closed envelopes method. Two PCA pumps (Lifecare® 4200, Abbott Laboratories, Chicago, IL, USA), one filled with saline and one with fentanyl 25 µg kg–1, were connected to the epidural catheter or to an i.v. cannula. In the PCA-IV group, the i.v. pump contained fentanyl and the cervical epidural catheter contained saline, while these were reversed for the PCA-Epid group. The two pumps were linked with one cable allowing synchronized delivery of identical bolus doses. On first complaint of pain, each patient was given an initial loading dose of fentanyl 1.5 µg kg–1 via the PCA device.
The PCA settings were identical for the two pumps in the two groups. The analgesic maintenance dose was set at 25 µg (i.e. 1 ml), with a lockout interval of 10 min. The maximum cumulative dose was set at 400 µg fentanyl every 4 h. If the VAS score was more than 5 for more than 1 h, the physician in charge of the intensive care unit could change the bolus dose to 50 µg, without changing the lockout interval.
I.V. methylprednisolone (1 mg kg–1 day–1) was administered to every patient, perioperatively and then at 8 AM every day.
The study lasted 48 h from the end of surgery during which time the patients were nursed in a postoperative care unit. Their ventilatory frequency and arterial oxygen saturation were monitored continuously and arterial blood gases were measured 12, 24 and 48 h after surgery. All patients received supplemental oxygen (FIO2: 50%) through the laryngeal cannula. Oxygen supplementation was stopped 15 min before arterial blood gas sampling. Pain relief was scored by the patient using the VAS every hour for the first 8 h and then every 2 h. The VAS pain scores were measured at rest and during swallowing. All VAS pain scores were assessed at the same time, following a standardized order (at rest, then after swallowing). All VAS scores were recorded by the nursing staff, who were not aware of the randomization group. All changes in the PCA devices were made by physicians not involved in the VAS score evaluation. Patients were also questioned as to the presence of nausea, vomiting, pruritus and difficult voiding.
Severe sedation was defined as a Ramsay Scale greater than 3 and was noted by the nursing staff. Episodes of respiratory depression, defined as a ventilatory frequency <8 min–1 or 
<90%, were also noted. Fentanyl consumption and the number of demands made to the PCA pumps were quantified with a printout of each patient's PCA usage every 2 h.
The data are expressed as mean (SD) except for VAS scores, cumulative fentanyl consumption and cumulative number of PCA demands which are expressed as median and interquartile range. Categorical data were analysed using Fisher's exact test. The respiratory variables were analysed using a two way ANOVA for repeated measures. The Mann–Whitney U-test was used to compare the two groups of patients for VAS scores at each time of the study, fentanyl consumption and PCA demands. A Tukey correction for multiple comparisons was applied for the VAS scores (n=6 comparisons). P<0.05 was considered statistically significant.
We chose the VAS pain score reduction at rest 6 h after surgery as the primary end point to calculate the required sample size for this clinical study. The number of patients was calculated using the results of a preliminary investigation in which we determined that, with PCA-IV fentanyl, the mean VAS score was of 3.8 (2.3). The required sample size was calculated to be 24 patients per group to detect with a power of 80% and 
=0.05 a difference of at least 50% in VAS score. Power and sample calculations were made using the PowerTM and PrecisionTM software (Englewood, NJ, USA). The statistical analysis was performed using the StatviewTM package (Abacus Concepts Inc., Berkeley, CA, USA).
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Results |
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Forty-six patients were enrolled and 42 completed the study, 20 in the PCA-Epid group and 22 in the PCA-IV group. Three patients who did not complete the study were in the PCA-IV group (one failure to puncture the epidural space, two postoperative dislodgement of epidural catheter) and one patient was from the PCA-Epid group (failure to puncture the epidural space). The patients' characteristics are summarized in Table 1. All patients were long time smokers with chronic bronchitis. The VAS scores at rest were significantly lower for the PCA-Epid group compared with the PCA-IV group at 2 and 6 h after the end of surgery (Fig. 1). The VAS pain scores at rest were in the PCA-Epid group 1.75 (3.25) and 1.75 (3) vs 5.5 (5.25) and 3.25 (3) in the PCA-IV group, 2 and 6 h after surgery respectively. Furthermore, a mean VAS pain score <3 which defines an adequate analgesia was observed from the 2nd postoperative hour in the PCA-Epid group but only from the 36th postoperative hour in the PCA-IV group.
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No difference was measured between the two groups in the VAS scores when swallowing during the whole duration of the study (Fig. 2). Cumulative fentanyl consumption was comparable in the two groups [PCA-Epid group: 1412 µg (912), PCA-IV group: 1287 µg (1200)] and the cumulative number of demands [PCA-Epid group: 68 (76), PCA-IV group: 75 (122)]. There were no changes in the PCA settings as defined in the study protocol.
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There was no clinical respiratory depression and no episode of severe sedation noted by the nursing staff. The PaO2 showed a significant decrease between the preoperative and postoperative periods in the PCA-IV group and a significant decrease between the preoperative period and 24 and 48 h after surgery in the PCA-Epid group; this decrease was identical in the two groups at 48 h after surgery. There were no differences in preoperative and postoperative PaCO2 in the two groups (Table 2).
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The incidence of side-effects was similar in the two groups (Table 1). No treatment was required other than ondansetron for vomiting.
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Discussion |
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The i.v. route is the common way of providing postoperative analgesia for pharyngolaryngeal surgery. Our study compares i.v. and cervical epidural opioid administration for postoperative analgesia and demonstrates that cervical epidural administration of fentanyl provides better analgesia at rest in the first 6 h after operation when compared with i.v. administration but does not decrease total fentanyl dose requirements. In some previous studies, authors showed no difference in fentanyl dose requirements between lumbar or thoracic epidural and i.v. routes with equivalent analgesia.7 8 14 15 Other studies show either a significant decrease of fentanyl requirement when administered epidurally with equivalent analgesia16 17 or equivalent fentanyl requirements with better analgesia.12 13 Our findings are consistent with the latter studies.
The PCA device enables patients to titrate and maintain analgesia to their own level. In our study, i.v. administration of fentanyl did not provide as good a level of analgesia as cervical epidural administration did. The PCA settings were identical in the two groups, as in other studies comparing epidural and i.v. fentanyl administration with randomized, double-blind methodology.10 12 16 Physicians in charge of the postoperative care unit could modify these settings if VAS scores were too high for a certain time. Some patients in the PCA-IV group had VAS scores reaching the limit but not for a long enough time to have the settings changed. Nonetheless, this may have influenced the results because of an induced limitation of drug consumption in the PCA-IV group.
Our study does not include plasma fentanyl concentrations. However, plasma fentanyl concentrations after lumbar or thoracic epidural administration have been measured with conflicting results.15 17 Dura mater permeability and vascular absorption of lipophilic drugs after epidural injection are poorly understood.18 19 Whatever the contribution of vascular absorption of epidurally administered fentanyl in our results, cervical epidural administration is more effective for initial analgesia at rest after laryngeal surgery than i.v. administration.
The nociceptive stimuli during swallowing are principally mediated by cranial nerves IX and X.20 As these nerves are not affected by cervical epidural analgesia, the absence of benefit in the PCA-Epid group during swallowing is not surprising. However, our study lacks the power to exclude such an effect.
Surprisingly, the incidence of side-effects was similar in the two groups. In contrast to other studies,6 21 there was no increase in pruritus or vomiting when fentanyl was administered epidurally. The small number of patients included in the study could be responsible for this result.
The choice of fentanyl as analgesic agent was motivated by the fact that cervical epidural administration of local anaesthetics affects pulmonary function.5 22 Local anaesthetics in combination with fentanyl could have provided better pain relief. The significant decrease of PaO2 between the preoperative and postoperative period is identical in the two groups, suggesting that this effect is not related to the route of fentanyl administration. The equivalent levels of PaCO2 between the preoperative and postoperative period suggests that the PaO2 reduction is not related to alveolar hypoventilation. The postoperative hypoxaemia may be the result of ventilation–perfusion mismatching in the basal pulmonary regions. Microatelectasis may be induced by frequent removal of the tracheal cannula during the surgical procedure and by reduction in the inspiratory muscle tone and diaphragmatic excursion as a result of long-lasting action of local anaesthetics used during the intraoperative period.5 There was no episode of clinical respiratory depression as defined in the protocol. However, epidural administration of fentanyl should be considered as a technique with the potential to induce respiratory depression.
In conclusion, our results demonstrate that either i.v. or cervical epidural fentanyl administration by means of a PCA device provide effective analgesia after laryngeal cancer surgery. Cervical epidural fentanyl administration provided significantly better analgesia at rest principally the initial 6 h after operation. This result was obtained without a decrease in fentanyl consumption, no differences in side-effects between the administration routes, no episode of clinical respiratory depression but equivalent postoperative hypoxaemia. It is our view that the clinical benefits of cervical epidural administration of fentanyl are insufficient when compared with the possible complications of the technique for us to recommend it for providing analgesia after pharyngolaryngeal surgery.
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