PROSPECT methodology for developing procedure-specific pain management recommendations: an update.

The procedure-specific postoperative pain management (PROSPECT) working group develops evidence-based pain management recommendations. PROSPECT methodology is unique and rigorous. However, several limitations were recognised that needed to be addressed, and several new factors were identified that improved PROSPECT methodology. The aim of this article is to present updated PROSPECT methodology for development of recommendations for procedure-specific pain management, focusing on the methodological revisions we will implement. In future, included randomised clinical trials will need to be prospectively registered on a publicly accessible clinical trials database and the study design, including the primary outcome in the registration, should coincide with that in the published manuscript. Placebo-controlled studies in which the analgesic intervention of interest is solely paracetamol, non-steroidal anti-inflammatory drugs, cyclo-oxygenase-2-specific inhibitors or opioids will not be included. Studies comparing one drug in a particular class with another in the same class will also not be included. Future projects will use the Cochrane Collaboration risk of bias tool for quality of reporting of methodology and results. A modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach will be used for grading of level of evidence and strength of recommendations. Finally, the updated PROSPECT methodology addresses several other limitations and implements new factors that all add rigour and transparency to developing procedure-specific pain management recommendations.

Neurodevelopmental outcomes after prenatal exposure to anaesthesia for maternal surgery: a propensity-score weighted bidirectional cohort study.

Up to 1% of pregnant women undergo anaesthesia for non-obstetric surgery. This study investigated neurodevelopmental outcomes after prenatal anaesthesia for maternal surgery. A bidirectional cohort study of children born between 2001 and 2018 was performed: neurodevelopmental outcomes of children who had received prenatal anaesthesia for maternal surgery were prospectively compared with unexposed children, with exposure status being assessed retrospectively. Children exposed to anaesthesia for obstetric and fetal surgery were excluded. The primary outcome was the global executive composite of the behaviour rating inventory of executive function score. Our secondary outcomes were: total problems; internalising problems and externalising problems derived from the child behaviour checklist; psychiatric diagnoses; and learning disorders. In 90% of exposed children, there was a single mean (SD) antenatal anaesthesia exposure lasting 91(94) min. There was a broad spectrum of indications, with abdominal surgery being most frequent. Parents of 129 exposed (response rate 68%) and 453 unexposed (response rate 63%) children participated. There were no arguments for non-response bias. After propensity weighting, there were no statistically significant differences in primary outcome, with a weighted mean difference (95%CI) of exposed minus unexposed children of 1.9 (-0.4-4.2), p = 0.10; or any of the secondary outcomes. Sensitivity analyses confirmed the robustness. Exploratory analyses, however, showed significant differences in certain subgroups for the primary outcome, (e.g. for intra-abdominal surgery, exposure duration > 1 h) and some cognitive subdomains (e.g. working memory and attention). This bidirectional cohort study, the largest investigation on the subject to date, has found no evidence in the general population for an association between prenatal exposure to anaesthesia and impaired neurodevelopmental outcomes.

High-volume patient-controlled epidural vs. programmed intermittent epidural bolus for labour analgesia: a randomised controlled study.

The aim of neuraxial analgesia is to achieve excellent pain relief with the fewest adverse effects. The most recently introduced technique for epidural analgesia maintenance is the programmed intermittent epidural bolus. In a recent study, we compared this with patient-controlled epidural analgesia without a background infusion and found that a programmed intermittent epidural bolus was associated with less breakthrough pain, lower pain scores, higher local anaesthetic consumption and comparable motor block. However, we had compared 10 ml programmed intermittent epidural boluses with 5 ml patient-controlled epidural analgesia boluses. To overcome this potential limitation, we designed a randomised, multicentre non-inferiority trial using 10 ml boluses in each group. The primary outcome was the incidence of breakthrough pain and total analgesic intake. Secondary outcomes included motor block; pain scores; patient satisfaction; and obstetric and neonatal outcomes. The trial was considered positive if two endpoints were met: non-inferiority of patient-controlled epidural analgesia with respect to breakthrough pain; and superiority of patient-controlled epidural analgesia with respect to local anaesthetic consumption. A total of 360 nulliparous women were allocated randomly to patient-controlled epidural analgesia-only or programmed intermittent epidural bolus groups. The patient-controlled group received 10 ml boluses of ropivacaine 0.12% with sufentanil 0.75 µg.ml-1 ; the programmed intermittent group received 10 ml boluses supplemented by 5 ml patient-controlled boluses. The lockout period was 30 min in each group and the maximum allowed hourly local anaesthetic/opioid consumption was identical between the groups. Breakthrough pain was similar between groups (11.2% patient controlled vs. 10.8% programmed intermittent, p = 0.003 for non-inferiority). Total ropivacaine consumption was lower in the PCEA-group (mean difference 15.3 mg, p < 0.001). Motor block, patient satisfaction scores and maternal and neonatal outcomes were similar across both groups. In conclusion, patient-controlled epidural analgesia is non-inferior to programmed intermittent epidural bolus if equal volumes of patient-controlled epidural analgesia are used to maintain labour analgesia and superior with respect to local anaesthetic consumption.

PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations.

Video-assisted thoracoscopic surgery has become increasingly popular due to faster recovery times and reduced postoperative pain compared with thoracotomy. However, analgesic regimens for video-assisted thoracoscopic surgery vary significantly. The goal of this systematic review was to evaluate the available literature and develop recommendations for optimal pain management after video-assisted thoracoscopic surgery. A systematic review was undertaken using procedure-specific postoperative pain management (PROSPECT) methodology. Randomised controlled trials published in the English language, between January 2010 and January 2021 assessing the effect of analgesic, anaesthetic or surgical interventions were identified. We retrieved 1070 studies of which 69 randomised controlled trials and two reviews met inclusion criteria. We recommend the administration of basic analgesia including paracetamol and non-steroidal anti-inflammatory drugs or cyclo-oxygenase-2-specific inhibitors pre-operatively or intra-operatively and continued postoperatively. Intra-operative intravenous dexmedetomidine infusion may be used, specifically when basic analgesia and regional analgesic techniques could not be given. In addition, a paravertebral block or erector spinae plane block is recommended as a first-choice option. A serratus anterior plane block could also be administered as a second-choice option. Opioids should be reserved as rescue analgesics in the postoperative period.

PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations.

Caesarean section is associated with moderate-to-severe postoperative pain, which can influence postoperative recovery and patient satisfaction as well as breastfeeding success and mother-child bonding. The aim of this systematic review was to update the available literature and develop recommendations for optimal pain management after elective caesarean section under neuraxial anaesthesia. A systematic review utilising procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in the English language between 1 May 2014 and 22 October 2020 evaluating the effects of analgesic, anaesthetic and surgical interventions were retrieved from MEDLINE, Embase and Cochrane databases. Studies evaluating pain management for emergency or unplanned operative deliveries or caesarean section performed under general anaesthesia were excluded. A total of 145 studies met the inclusion criteria. For patients undergoing elective caesarean section performed under neuraxial anaesthesia, recommendations include intrathecal morphine 50-100 µg or diamorphine 300 µg administered pre-operatively; paracetamol; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone administered after delivery. If intrathecal opioid was not administered, single-injection local anaesthetic wound infiltration; continuous wound local anaesthetic infusion; and/or fascial plane blocks such as transversus abdominis plane or quadratus lumborum blocks are recommended. The postoperative regimen should include regular paracetamol and non-steroidal anti-inflammatory drugs with opioids used for rescue. The surgical technique should include a Joel-Cohen incision; non-closure of the peritoneum; and abdominal binders. Transcutaneous electrical nerve stimulation could be used as analgesic adjunct. Some of the interventions, although effective, carry risks, and consequentially were omitted from the recommendations. Some interventions were not recommended due to insufficient, inconsistent or lack of evidence. Of note, these recommendations may not be applicable to unplanned deliveries or caesarean section performed under general anaesthesia.

Intrathecal catheter use after accidental dural puncture in obstetric patients: literature review and clinical management recommendations.

If an accidental dural puncture occurs, one option is to insert a catheter and use it as an intrathecal catheter. This avoids the need for a further injection and can rapidly provide labour analgesia and anaesthesia for caesarean section. However, there are no recommendations for managing intrathecal catheters and, therefore, significant variation in clinical practice exists. Mismanagement of the intrathecal catheter can lead to increased motor block, high spinal anaesthesia, drug error, hypotension and fetal bradycardia. Care must be taken with an intrathecal catheter to adhere to strict aseptic technique, meticulous labelling, cautious administration of medications and good communication with the patient and other staff. Every institution considering the use of intrathecal catheters should establish a protocol. For labour analgesia, we recommend the use of dilute local anaesthetic agents and opioids. For caesarean section anaesthesia, gradual titration to the level of the fourth thoracic dermatome, with full monitoring, in a facility equipped to manage complications, should be performed using local anaesthetics combined with lipophilic opioids and morphine or diamorphine. Although evidence of the presence and duration of intrathecal catheters on the development of post-dural puncture headache and need for epidural blood patch is limited, we suggest considering leaving the intrathecal catheter in for 24 hours to reduce the chance of developing a post-dural puncture headache while maintaining precautions to avoid drug error and cerebrospinal fluid leakage. Injection of sterile normal saline into the intrathecal catheter may reduce post-dural puncture headache. The level of evidence for these recommendations was low.

PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations.

The aim of this systematic review was to develop recommendations for the management of postoperative pain after primary elective total hip arthroplasty, updating the previous procedure-specific postoperative pain management (PROSPECT) guidelines published in 2005 and updated in July 2010. Randomised controlled trials and meta-analyses published between July 2010 and December 2019 assessing postoperative pain using analgesic, anaesthetic, surgical or other interventions were identified from MEDLINE, Embase and Cochrane databases. Five hundred and twenty studies were initially identified, of which 108 randomised trials and 21 meta-analyses met the inclusion criteria. Peri-operative interventions that improved postoperative pain include: paracetamol; cyclo-oxygenase-2-selective inhibitors; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone. In addition, peripheral nerve blocks (femoral nerve block; lumbar plexus block; fascia iliaca block), single-shot local infiltration analgesia, intrathecal morphine and epidural analgesia also improved pain. Limited or inconsistent evidence was found for all other approaches evaluated. Surgical and anaesthetic techniques appear to have a minor impact on postoperative pain, and thus their choice should be based on criteria other than pain. In summary, the analgesic regimen for total hip arthroplasty should include pre-operative or intra-operative paracetamol and cyclo-oxygenase-2-selective inhibitors or non-steroidal anti-inflammatory drugs, continued postoperatively with opioids used as rescue analgesics. In addition, intra-operative intravenous dexamethasone 8-10 mg is recommended. Regional analgesic techniques such as fascia iliaca block or local infiltration analgesia are recommended, especially if there are contra-indications to basic analgesics and/or in patients with high expected postoperative pain. Epidural analgesia, femoral nerve block, lumbar plexus block and gabapentinoid administration are not recommended as the adverse effects outweigh the benefits. Although intrathecal morphine 0.1 mg can be used, the PROSPECT group emphasises the risks and side-effects associated with its use and provides evidence that adequate analgesia may be achieved with basic analgesics and regional techniques without intrathecal morphine.

Measuring vincristine-induced peripheral neuropathy in children with cancer: validation of the Dutch pediatric-modified Total Neuropathy Score.

PURPOSE: The aims were to evaluate the construct validity and reliability of the Dutch version of the pediatric-modified Total Neuropathy Score (ped-mTNS) for assessing vincristine-induced peripheral neuropathy (VIPN) in Dutch pediatric oncology patients aged 5-18 years. METHODS: Construct validity (primary aim) of the ped-mTNS was determined by testing hypotheses about expected correlation between scores of the ped-mTNS (range: 0-32) and the Common Terminology Criteria for Adverse Events (CTCAE) (range: 0-18) for patients and healthy controls and by comparing patients and controls regarding their total ped-mTNS scores and the proportion of children identified with VIPN. Inter-rater and intra-rater reliability and measurement error (secondary aims) were assessed in a subgroup of study participants. RESULTS: Among the 112 children (56 patients and 56 age- and gender-matched healthy controls) evaluated, correlation between CTCAE and ped-mTNS scores was as expected (moderate (r = 0.60)). Moreover, as expected, patients had significantly higher ped-mTNS scores and more frequent symptoms of VIPN compared with controls (both p < .001). Reliability as measured within the intra-rater group (n = 10) (intra-class correlation coefficient (ICCagreement) = 0.64, standard error of measurement (SEMagreement) = 2.92, and smallest detectable change (SDCagreement) = 8.1) and within the inter-rater subgroup (n = 10) (ICCagreement = 0.63, SEMagreement = 3.7, and SDCagreement = 10.26) indicates insufficient reliability. CONCLUSION: The Dutch version of the ped-mTNS appears to have good construct validity for assessing VIPN in a Dutch pediatric oncology population, whereas reliability appears to be insufficient and measurement error high. To improve standardization of VIPN assessment in children, future research aimed at evaluating and further optimizing the psychometric characteristics of the ped-mTNS is needed.

PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations.

Analgesic protocols used to treat pain after breast surgery vary significantly. The aim of this systematic review was to evaluate the available literature on this topic and develop recommendations for optimal pain management after oncological breast surgery. A systematic review using preferred reporting items for systematic reviews and meta-analysis guidance with procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials assessing postoperative pain using analgesic, anaesthetic or surgical interventions were identified. Seven hundred and forty-nine studies were found, of which 53 randomised controlled trials and nine meta-analyses met the inclusion criteria and were included in this review. Quantitative analysis suggests that dexamethasone and gabapentin reduced postoperative pain. The use of paravertebral blocks also reduced postoperative pain scores, analgesia consumption and the incidence of postoperative nausea and vomiting. Intra-operative opioid requirements were documented to be lower when a pectoral nerves block was performed, which also reduced postoperative pain scores and opioid consumption. We recommend basic analgesics (i.e. paracetamol and non-steroidal anti-inflammatory drugs) administered pre-operatively or intra-operatively and continued postoperatively. In addition, pre-operative gabapentin and dexamethasone are also recommended. In major breast surgery, a regional anaesthetic technique such as paravertebral block or pectoral nerves block and/or local anaesthetic wound infiltration may be considered for additional pain relief. Paravertebral block may be continued postoperatively using catheter techniques. Opioids should be reserved as rescue analgesics in the postoperative period. Research is needed to evaluate the role of novel regional analgesic techniques such as erector spinae plane or retrolaminar plane blocks combined with basic analgesics in an enhanced recovery setting.

Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study†.

The programmed intermittent epidural bolus technique has shown superiority to continuous epidural infusion techniques, with or without patient-controlled epidural analgesia for pain relief, reduced motor block and patient satisfaction. Many institutions still use patient-controlled epidural analgesia without a background infusion, and a comparative study between programmed intermittent epidural bolus and patient-controlled epidural analgesia without a background infusion has not yet been performed. We performed a randomised, two-centre, double-blind, controlled trial of these two techniques. The primary outcome was the incidence of breakthrough pain requiring a top-up dose by an anaesthetist. Secondary outcomes included: motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes. We recruited 130 nulliparous women who received initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75 µg·ml-1 . The programmed intermittent epidural bolus group had a programmed bolus of 10 ml every hour, with on-demand patient-controlled epidural analgesia boluses of 5 ml with a 20 min lockout, and the patient-controlled epidural analgesia group had a 5 ml bolus with a 12 min lockout interval; the potential maximum volume per hour was the same in both groups. The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively. There was a significant difference in motor block (modified Bromage score ≤ 4) frequency between groups, programmed intermittent epidural bolus group 1 (1.6%) vs. patient-controlled epidural analgesia group 8 (13.1%); p = 0.015. The programmed intermittent epidural bolus group had greater local anaesthetic consumption with fewer patient-controlled epidural analgesia boluses. Patient satisfaction scores and obstetric or neonatal outcomes were not different between groups. In conclusion, we found that a programmed intermittent epidural bolus technique using 10 ml programmed boluses and 5 ml patient-controlled epidural analgesia boluses was superior to a patient-controlled epidural analgesia technique using 5 ml boluses and no background infusion.

Development of evidence-based recommendations for procedure-specific pain management: PROSPECT methodology.

Effective peri-operative pain management is a prerequisite for optimal recovery after surgery. Despite published evidence-based guidelines from several professional groups, postoperative pain management remains inadequate. The procedure-specific pain management (PROSPECT) collaboration consists of anaesthetists and surgeons with broad international representation that provide healthcare professionals with practical and evidence-based recommendations formulated in a way that facilitates clinical decision-making across all stages of the peri-operative period on a procedure-specific basis. The aim of this manuscript is to provide a detailed description of the current PROSPECT methodology with the intention of providing the rigour and transparency in which procedure-specific pain management recommendations are developed. The high methodological standards of the recommendations should improve the quality of clinical practice.

PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations.

Rotator cuff repair can be associated with significant and difficult to treat postoperative pain. We aimed to evaluate the available literature and develop recommendations for optimal pain management after rotator cuff repair. A systematic review using procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in English from 1 January 2006 to 15 April 2019 assessing postoperative pain after rotator cuff repair using analgesic, anaesthetic or surgical interventions were identified from MEDLINE, Embase and Cochrane Databases. Out of 322 eligible studies identified, 59 randomised controlled trials and one systematic review met the inclusion criteria. Pre-operative and intra-operative interventions that improved postoperative pain were paracetamol, cyclo-oxygenase-2 inhibitors, intravenous dexamethasone, regional analgesia techniques including interscalene block or suprascapular nerve block (with or without axillary nerve block) and arthroscopic surgical technique. Limited evidence was found for pre-operative gabapentin, perineural adjuncts (opioids, glucocorticoids, or α-2-adrenoceptor agonists added to the local anaesthetic solution) or postoperative transcutaneous electrical nerve stimulation. Inconsistent evidence was found for subacromial/intra-articular injection, and for surgical technique-linked interventions, such as platelet-rich plasma. No evidence was found for stellate ganglion block, cervical epidural block, specific postoperative rehabilitation protocols or postoperative compressive cryotherapy. The analgesic regimen for rotator cuff repair should include an arthroscopic approach, paracetamol, non-steroidal anti-inflammatory drugs, dexamethasone and a regional analgesic technique (either interscalene block or suprascapular nerve block with or without axillary nerve block), with opioids as rescue analgesics. Further randomised controlled trials are required to confirm the influence of the recommended analgesic regimen on postoperative pain relief.

Simplified algorithm for the prevention of postoperative nausea and vomiting: a before-and-after study.

BACKGROUND: Poor adherence to guidelines aimed at reducing the incidence of postoperative nausea and vomiting (PONV) is well known. In a before-and-after study, we tested the effectiveness of a simplified algorithm for PONV prophylaxis on the incidence of PONV. METHODS: In the first audit, we examined the adherence to our institutional guidelines for PONV prevention. In response to the results of this audit, we introduced a simplified algorithm for PONV prevention [female patients receiving triple prophylaxis (dexamethasone and ondansetron plus either a target-controlled infusion with propofol or droperidol) and male patients receiving double prophylaxis, dexamethasone, and ondansetron]. The impact of the simplification of the PONV algorithm was evaluated in a second audit. In both audits, we reviewed the medical records of all adult patients undergoing elective non-cardiac non-day-case surgery under general anaesthesia and being admitted to our post-anaesthesia care unit during two arbitrarily chosen weeks. We assessed the incidence of nausea, vomiting, and PONV after 1 and 24 h, and the compliance with the departmental algorithm for PONV prophylaxis. RESULTS: After simplification of the PONV algorithm, the overall incidence of PONV within 24 h after surgery was significantly lower than before the implementation of the simplified PONV algorithm (22% vs 33%, P=0.02). The PONV incidence within 1 h was comparable between the audits (11% vs 14%, P=0.45). The adherence to departmental guidelines for PONV prophylaxis was significantly higher after the implementation of the simplified PONV algorithm (46% vs 18%, P=0.0001). CONCLUSIONS: A simplified algorithm for PONV prophylaxis resulted in a significant reduction in the PONV incidence and better compliance with the PONV algorithm.

Combined spinal-epidural vs. spinal anaesthesia for caesarean section: meta-analysis and trial-sequential analysis.

Combined spinal-epidural and single-shot spinal anaesthesia are both used for caesarean section. It has been claimed in individual trials that combined spinal-epidural is associated with higher sensory spread and greater cardiovascular stability. We set out to gather all available evidence. We performed: a systematic literature search to identify randomised controlled trials comparing combined spinal-epidural with spinal anaesthesia for caesarean section: conventional meta-analysis; trial-sequential analysis; and assessment of trial quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Fifteen trials with high heterogeneity, including 1015 patients, were analysed. There was no significant difference between combined spinal-epidural and spinal anaesthesia for our primary outcomes maximum sensory height and vasopressor use (mg ephedrine equivalents). However, trial-sequential analysis suggested insufficient data and the GRADE scores showed 'very low' quality of evidence for these outcomes. The secondary outcomes hypotension, time for sensory block to recede to the level of T10, and the combined outcome of nausea and vomiting, did not differ significantly between the interventions. The block times were statistically significantly longer for combined spinal-epidural in individual trials, but only one trial showed a clinically meaningful difference (11 min). Based on this analysis, and taking into consideration all comparisons irrespective of whether drugs had been applied via the epidural route, there is not enough evidence to postulate any advantage compared with the spinal technique. Future analyses and studies need to examine the potential advantages of the combined spinal-epidural technique by using the epidural route intra- and/or postoperatively.

The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study.

The fascia iliaca compartment is the compartment confined by the fascia iliaca (FI) and a muscular layer formed by the iliac- and psoas muscle. This compartment creates a virtual tunnel that contains the femoral nerve (FN), the obturator nerve (ON), and the lateral femoral cutaneous nerve (LFCN) of the lumbar plexus. In this pilot study, we aimed to determine the suggested volume needed to reach the three target nerves of the lumbar plexus (FN, ON, and LFCN) with a single-injection ultrasound-guided supra-inguinal fascia iliaca compartment (S-FICB). A computer tomography (CT scan)-guided step-up/step-down sequence was used to determine the suggested injection volume to target all three nerves. Subsequently, an anatomist blinded for the injected volume and CT findings, dissected the cadavers, and evaluated the spread of dye underneath the fascia iliaca. In total, seven pelvic areas of four cadavers were evaluated on CT scan and dissected. Distribution of dye underneath the FI in relation to the FN, ON, and the LFCN was recorded in all dissected cadavers. Combining CT and dissection findings, the suggested volume to reach the FN, ON, and LFCN with an S-FICB was 40 mL.

Systemic lidocaine fails to improve postoperative morphine consumption, postoperative recovery and quality of life in patients undergoing posterior spinal arthrodesis. A double-blind, randomized, placebo-controlled trial.

BACKGROUND.: It is inconclusive whether the perioperative administration of systemic lidocaine provides effective postoperative analgesia and enhances recovery in major orthopaedic surgery. We hypothesised that in adolescent and adult patients undergoing posterior spinal arthrodesis, a perioperative lidocaine infusion would reduce opioid requirements during the first 24 postoperative h. METHODS.: 70 patients undergoing posterior arthrodesis were enrolled in this prospective, randomised, double-blind, placebo-controlled clinical trial. Patients received total i.v. anaesthesia with propofol and remifentanil and were randomized to an adjuvant therapy with either lidocaine [i.v.-bolus injection of 1.5 mg kg -1 at induction of anaesthesia, followed by an infusion of 1.5 mg kg -1 h -1 which was continued until six h after arrival at the post-anaesthesia care unit] or placebo (equal volumes of saline). Postoperative pain was treated with patient-controlled i.v. morphine. Primary endpoints of this study were morphine requirements in the first postoperative 24 h. RESULTS.: Systemic lidocaine did not decrease morphine requirements in the first 24 postoperative h [lidocaine-group: 48 (23) mg (mean( sd )) vs placebo-group: 51(19) mg, P = 0.22]. Likewise, groups were not different with respect to the severity of postoperative pain, morphine consumption after 48 and 72 h, incidence of postoperative nausea and vomiting, perioperative inflammation, time to recovery of intestinal function, hospital length of stay, and quality of life (assessed preoperatively and one month postoperatively using the SF-12 physical and mental composite scores). CONCLUSIONS.: In our study, systemic lidocaine had no analgesic benefits in posterior arthrodesis when added to an opioid-based anaesthetic regimen. CLINICAL TRIAL REGISTRATION.: Eudra CT 2012-005264-98.