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Recovery room analgesic requirements, pain scores, and recall of intraoperative pain were RESULTS: Significantly more patients in Group II (9/20) required.
Table of contents

PONV-prophylaxis was performed with dexamethasone 0. Neurophysiological monitoring including somatosensory and motor evoked potentials was used intraoperatively in the majority of patients. A subgroup analysis planned at the time the recruitment age had been extended was conducted for patients with an age between 12 and 18 yr undergoing scoliosis correction.

The study medication was administered to patients with default haemodynamic monitoring in the setting of a completely equipped operation theatre. This enabled immediate detection and management of potential adverse events.


Administration of study drugs was to be immediately stopped in case that the study subject showed signs of systemic toxicity metallic taste, tinnitus, headache, seizure activity and ECG irregularities. Also after leaving the operation room, all patients were closely monitored for the occurrence of eventual severe adverse events.

The sample size estimation was based on data from our clinical routine. As the estimate of the coefficient of variation was based on sparse data, we assumed a more conservative estimate for the CV i. To countervail potential drop-outs, we included 70 patients in total 35 in each group. The statistical analysis was primarily conducted on an intention-to-treat basis using SAS software version 9.

Additionally, we performed a per-protocol analysis after exclusion of patients with partial loss-to-follow-up.

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A Mann-Whitney U -test was used to compare the cumulative morphine usage primary outcome and other continuous or ordinal measurements between both groups. For the comparison of longitudinal measurements daily number of PCIA-boli, NRS for pain , a multivariate linear model for repeated measures was used adopting a direct likelihood approach. Kaplan-Meier estimates are given for hospital stay and time until first defecation. The latter were compared between the two groups using the log-rank Mantel—Cox test. In two sensitivity analyses, postoperative morphine consumption was compared between both groups after correction for the difference in preoperative use of analgesics and for postoperative use of clonidine using an approach presented by Schacht and colleagues The per-protocol-population see supplemental data included 69 patients, as one patient of the placebo group was admitted to the intensive care unit because of intraoperative massive haemorrhage with consecutive haemodynamic instability, rendering the assessment of the primary outcome impossible.

Patients in both groups did not differ with respect to patient characteristics, biometric and procedure-related data Table 1.

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Table 1 Patient characteristics. Patient characteristics. Cumulative morphine requirements milligrams in the first 24 postoperative h for the lidocaine and the placebo group. More subjects in the placebo- than in the lidocaine-group had chronic preoperative treatment with analgesics However, this did not explain the lack of a difference in postoperative morphine consumption. Both groups did not differ with respect to the postoperative administration of i. Pain scores as assessed with the numeric rating scale NRS for pain in both groups during the first three postoperative days.

Kaplan-Meier survival plot showing the time until first defecation A and hospital stay B. No significant difference was found for the time until first defecation and hospital stay between the lidocaine - and placebo group. Intraoperative data and secondary outcomes. Postoperative day 1 POD1. The serum concentrations of IL-6 and IL-1Ra did not differ significantly between the groups at any time point Table 2.

Incidence of adverse events did not differ significantly between groups Table 2. No patient receiving lidocaine reported subjective symptoms of local anaesthetic systemic toxicity. In our trial, we could not demonstrate any beneficial effect of i. Moreover, lidocaine failed to accelerate postoperative recovery, to shorten length of stay and to improve quality of life.

Our observations are in contrast with the findings of two studies published only after the start of our trial and also investigating the efficacy of systemic lidocaine in spine surgery. Moreover, the results of our study contradict several meta-analyses that demonstrated significant analgesic effects for the perioperative administration of systemic lidocaine, an improved gastro-intestinal recovery and a significant reduction in hospital length of stay. For other surgical procedures, data on the analgesic efficacy of lidocaine are much less convincing. Several studies in non-abdominal surgery including breast surgery, 13 total hip arthroplasty, 9 coronary artery bypass surgery 26 and in abdominal surgery not involving the intestines including renal surgery, 27 laparoscopic tubal ligation, 15 and laparoscopic prostatectomy 28 failed to demonstrate a significant analgesic effect of lidocaine.

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It is tempting to speculate why we - in contrast to the two above mentioned trials in spine surgery 5 , 10 and the meta-analyses in abdominal surgery 23—25 - found lidocaine to have no significant analgesic effects. First, the patients included in the two spine trials differed considerably from our study subjects. All our patients underwent complex and extensive surgery, with instrumentation of in average more than twice the number of levels than in the other studies.

Moreover, we included a subgroup consisting of adolescents known to show increased pain sensitivity. Second, our type of anaesthesia differed from that of the other spine trials in which no opioids where used intraoperatively. In the present study, a remifentanil-infusion was started at induction of anaesthesia and continued until the end of surgery. In addition, our patients received 0. If present at all in orthopaedic surgery, analgesic effects of lidocaine may have been masked by the intraoperative use of opioids.

Likewise, no analgesic effects were found for systemic lidocaine in total hip arthroplasty when sufentanil was given intraoperatively.

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Third, the dose with which systemic lidocaine was infused in our trial 1. This likely resulted in a higher cumulative lidocaine dose when compared with the other two trials. The failure of lidocaine to reduce morphine requirements should therefore not be attributed to possible underdosing. Fourth, the analgesic effects of lidocaine that have been reported in abdominal surgery are likely related to the improvement of bowel function, with a reduction of visceral pain caused by bowel distention.

Lidocaine seems to counteract both of these mechanisms, by attenuation of the inflammatory response 30 and by inhibition of the evoked and spontaneous activity of spinal neurons which are excited by colorectal distention. Consequently, we did not observe a reduction in the time to return of intestinal function in our trial.

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Fifth, cytokines are of crucial importance in several mechanisms underlying pain and hyperalgesia. Sixth, it has been demonstrated that the analgesic effects of lidocaine depend on the total dose of infused lidocaine. The fact that we failed to observe an analgesic effect can therefore most probably not be attributed to an insufficient duration of lidocaine treatment, as was suggested in the total hip arthroplasty trial. We did not find significant differences in PONV incidence.

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This result is in accordance with the results of the previous spine trials, in which no difference in PONV incidence could be observed between the groups. In contrast to several studies in abdominal surgery 30 , 31 , 40 , 41 and to one study in lumbar microdiscectomy, 10 hospital length of stay was not reduced by the treatment with lidocaine, most probably because lidocaine failed to produce positive effects on postoperative pain and bowel function, both of which are determining factors for hospital discharge.

We would like to note that our study is subject to multiple limitations. First, it can be discussed if the NRS for pain is an adequate tool for measuring the effect of lidocaine on pain control. The NRS is significantly influenced by the amount of opioids that have been given. However, in our trial, postoperative pain medication was standardized and no difference was found in opioid requirements between both groups. Second, we did not analyse the lidocaine concentrations in our patients.

However, both the dose and the duration of lidocaine treatment used in our study have been described to be effective in other clinical trials. Nevertheless, both treatment groups did not differ statistically regarding the age of the included patients. Fourth, our sample size estimation was based on the morphine consumption that had been observed in 10 preliminary adolescents, undergoing spine surgery in our institution before the start of our study.

During the study, we opened the recruitment to adult patients, hereby also including degenerative pathology. Theoretically, this could have affected severity of pain and hence may have resulted in greater variations of opioid requirements. However, the sample size calculation was based on an assumed CV of 0. Of note, this small underestimation was largely compensated for by the fact that we included 69 patients in total i. Hence, the negative result in the current study was likely not caused by a lack of power.

Fifth, the study was powered solely for the primary endpoint. It cannot be excluded that significant effects on secondary outcomes may be unveiled after inclusion of a larger patient number. Sixth, the use of remifentanil for intraoperative analgesia can be criticized. Remifentanil has been demonstrated to have N-methyl-D-aspartate agonistic properties, 43 eventually causing anti-analgesic effects in the postoperative period. The use of remifentanil was however mandatory in this study to allow neurophysiological monitoring somatosensory and motor evoked potentials in the majority of patients.

Last, we did not investigate whether lidocaine had beneficial effects on chronic post-surgical pain in our patient population. In conclusion, in spinal surgery, systemic lidocaine has no analgesic efficacy when added to opioid based balanced anaesthesia. Our findings add further evidence that multimodal analgesia with lidocaine is of limited or no value in orthopaedic surgery.

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Further research should focus on the characterization of patient groups that unambiguously benefit from perioperatively administered lidocaine, and on the clear identification of the putative mechanism of analgesic action. Study conduct: G. Data analysis: S. Writing paper: G. Revising paper: all authors. Supplementary material is available at British Journal of Anaesthesia online.

Assistance with the study: We would like to express our appreciation for our research nurse Christel Huygens and her team for their invaluable assistance. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search. Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents. Statistical analysis. Supplementary material.