Persistent Incisional Pain after Noncardiac Surgery: An International Prospective Cohort Study.

BACKGROUND: The purpose of this study was to determine the incidence, characteristics, impact, and risk factors associated with persistent incisional pain. The hypothesis was that patient demographics and perioperative interventions are associated with persistent pain. METHODS: This was a secondary analysis of an international prospective cohort study from 2012 to 2014. This study included patients who were 45 yr of age or older who underwent major inpatient noncardiac surgery. Data were collected perioperatively and at 1 yr after surgery to assess for the development of persistent incisional pain (pain present around incision at 1 yr after surgery). RESULTS: Among 14,831 patients, 495 (3.3%; 95% CI, 3.1 to 3.6) reported persistent incisional pain at 1 yr, with an average pain intensity of 3.6 ± 2.5 (0 to 10 numeric rating scale), with 35% and 14% reporting moderate and severe pain intensities, respectively. More than half of patients with persistent pain reported needing analgesic medications, and 85% reported interference with daily activities (denominator = 495 in the above proportions). Risk factors for persistent pain included female sex (P = 0.007), Asian ethnicity (P < 0.001), surgery for fracture (P < 0.001), history of chronic pain (P < 0.001), coronary artery disease (P < 0.001), history of tobacco use (P = 0.048), postoperative patient-controlled analgesia (P < 0.001), postoperative continuous nerve block (P = 0.010), insulin initiation within 24 h of surgery (P < 0.001), and withholding nonsteroidal anti-inflammatory medication or cyclooxygenase-2 inhibitors on the day of surgery (P = 0.029 and P < 0.001, respectively). Older age (P < 0.001), endoscopic surgery (P = 0.005), and South Asian (P < 0.001), Native American/Australian (P = 0.004), and Latin/Hispanic ethnicities (P < 0.001) were associated with a lower risk of persistent pain. CONCLUSIONS: Persistent incisional pain is a common complication of inpatient noncardiac surgery, occurring in approximately 1 in 30 adults. It results in significant morbidity, interferes with daily living, and is associated with persistent analgesic consumption. Certain demographics, ethnicities, and perioperative practices are associated with increased risk of persistent pain.

Interventional treatments for chronic, axial or radicular, non-cancer, spinal pain: a protocol for a systematic review and network meta-analysis of randomised trials.

INTRODUCTION: Chronic, non-cancer, axial or radicular spinal pain is a common condition associated with considerable socioeconomic burden. Clinicians frequently offer patients various interventional procedures for the treatment of chronic spine pain; however, the comparative effectiveness and safety of available procedures remains uncertain. METHODS: We will conduct a systematic review of randomised controlled trials that explores the effectiveness and harms of interventional procedures for the management of axial or radicular, chronic, non-cancer, spine pain. We will identify eligible studies through a systematic search of Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science from inception without language restrictions. Eligible trials will: (1) enrol primarily adult patients (≥18 years old) with axial or radicular, chronic, non-cancer, spine pain, (2) randomise patients to different, currently available, interventional procedures or to an interventional procedure and a placebo/sham procedure or usual care, and (3) measure outcomes at least 1 month after randomisation.Pairs of reviewers will independently screen articles identified through searches and extract information and assess risk of bias of eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias. We will use frequentist random-effects network meta-analyses to assess the relative effects of interventional procedures, and five a priori hypotheses to explore between studies subgroup effects. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty in evidence for each outcome, including direct, indirect and network estimates. ETHICS AND DISSEMINATION: No research ethics approval is required for this systematic review, as no confidential patient data will be used. We will disseminate our findings through publication in a peer-reviewed journal and conference presentations, and our review will support development of a BMJ Rapid Recommendations providing contextualised clinical guidance based on this body of evidence. PROSPERO REGISTRATION NUMBER: CRD42020170667.

Opioid-sparing effects of medical cannabis or cannabinoids for chronic pain: a systematic review and meta-analysis of randomised and observational studies.

OBJECTIVE: To assess the efficacy and harms of adding medical cannabis to prescription opioids among people living with chronic pain. DESIGN: Systematic review. DATA SOURCES: CENTRAL, EMBASE and MEDLINE. MAIN OUTCOMES AND MEASURES: Opioid dose reduction, pain relief, sleep disturbance, physical and emotional functioning and adverse events. STUDY SELECTION CRITERIA AND METHODS: We included studies that enrolled patients with chronic pain receiving prescription opioids and explored the impact of adding medical cannabis. We used Grading of Recommendations Assessment, Development and Evaluation to assess the certainty of evidence for each outcome. RESULTS: Eligible studies included five randomised trials (all enrolling chronic cancer-pain patients) and 12 observational studies. All randomised trials instructed participants to maintain their opioid dose, which resulted in a very low certainty evidence that adding cannabis has little or no impact on opioid use (weighted mean difference (WMD) -3.4 milligram morphine equivalent (MME); 95% CI (CI) -12.7 to 5.8). Randomised trials provided high certainty evidence that cannabis addition had little or no effect on pain relief (WMD -0.18 cm; 95% CI -0.38 to 0.02; on a 10 cm Visual Analogue Scale (VAS) for pain) or sleep disturbance (WMD -0.22 cm; 95% CI -0.4 to -0.06; on a 10 cm VAS for sleep disturbance; minimally important difference is 1 cm) among chronic cancer pain patients. Addition of cannabis likely increases nausea (relative risk (RR) 1.43; 95% CI 1.04 to 1.96; risk difference (RD) 4%, 95% CI 0% to 7%) and vomiting (RR 1.5; 95% CI 1.01 to 2.24; RD 3%; 95% CI 0% to 6%) (both moderate certainty) and may have no effect on constipation (RR 0.85; 95% CI 0.54 to 1.35; RD -1%; 95% CI -4% to 2%) (low certainty). Eight observational studies provided very low certainty evidence that adding cannabis reduced opioid use (WMD -22.5 MME; 95% CI -43.06 to -1.97). CONCLUSION: Opioid-sparing effects of medical cannabis for chronic pain remain uncertain due to very low certainty evidence.PROSPERO registration numberCRD42018091098.

The role of anxiety and related states in pediatric postsurgical pain.

Background: Nearly 20% of children and adolescents have pain with disability 1 year after surgery, and they experience poor sleep, school absence, and decreased activities. Negative clinical, psychological, and developmental effects include greater pain medication use, longer recovery, and fear of future medical care. Research has found psychological and family influences (i.e., child and parental anxiety) on pediatric chronic postsurgical pain (CPSP), but a better understanding of the role of perioperative anxiety and its related states in predicting pediatric postsurgical pain is needed. The poor understanding of the causes of child CPSP can lead to misdiagnosis and inadequate treatment, with significant short- and long-term effects. Objectives: The aim of this review was to summarize the literature on children's perioperative anxiety and parental anxiety in relation to acute postsurgical pain, CPSP, and pain trajectories. We also examined other related psychological factors (i.e., anxiety sensitivity, catastrophizing, pain anxiety, and fear of pain) in relation to pediatric acute and chronic postsurgical pain. Lastly, we discuss the interventions that may be effective in reducing children's and parents' preoperative anxiety. Conclusions: Our findings may improve the understanding of the causes of CPSP and highlight the gaps in research and need for further study.

Contexte: Près de 20 % des enfants et adolescents ont des douleurs avec incapacité un après la chirurgie, et ils ont un mauvais sommeil, des absences scolaires et une diminution de leurs activités. Les effets cliniques, psychologiques et développementaux négatifs comprennent une utilisation accrue des analgésiques, une récupération plus longue et la peur des soins médicaux futurs. La recherche a révélé des influences psychologiques et familiales (c.-à-d. de l'anxiété chez les enfants et les parents) sur la douleur chronique postchirurgicale pédiatrique, mais une meilleure compréhension du rôle de l'anxiété périopératoire et ses états associés pour prédire la douleur postchirurgicale pédiatrique est nécessaire. Une mauvaise compréhension des causes de la douleur chronique postchirurgicale pédiatrique peut entraîner un diagnostic erroné et un traitement inadéquat, avec des effets importants à court et à long terme.Objectifs: Le but de cette revue était de résumer la littérature sur l'anxiété périopératoire des enfants et l'anxiété parentale en lien avec la douleur postchirurgicale aiguë, la douleur chronique postchirurgicale et les trajectoires de la douleur. Nous avons aussi examiné d'autres facteurs psychologiques connexes (ex. : sensibilité à l'anxiété, catastrophisme, anxiété de la douleur, et peur de la douleur) en lien avec la douleur chronique postchirurgicale pédiatrique aigue. Enfin, nous discutons des interventions qui peuvent être efficaces pour réduire l'anxiété préopératoire des enfants et des parents.Conclusions: Nos résultats peuvent améliorer la compréhension des causes de la douleur chronique postchirurgicale et mettre en évidence les lacunes dans la recherche, ainsi que la nécessité d'études plus poussées.

Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study.

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial.

Persistent postsurgical pain is defined as pain localized to the area of surgery of a duration of ≥2 months and is, unfortunately, a common complication after breast cancer surgery. Although there is insufficient evidence to support any preventative strategy, prior literature suggests the possible efficacy of intravenous lidocaine and perioperative pregabalin in preventing persistent pain after surgery. To determine feasibility of conducting a larger definitive trial, we conducted a multicenter 2 × 2 factorial, randomized, placebo-controlled pilot trial of 100 female patients undergoing breast cancer surgery. Patients were randomized to receive an intraoperative lidocaine infusion (1.5 mg/kg bolus followed by 2 mg/kg/h) or placebo and perioperative pregabalin (300 mg preoperatively, 75 mg twice daily for 9 days) or placebo. All feasibility criteria were surpassed; recruitment of 100 patients was accomplished within 42 weeks, with a follow-up rate of 100% and study drug compliance of ≥80%. At 3 months, 53% of patients reported persistent neuropathic pain. Although there was no interaction between lidocaine and pregabalin, lidocaine decreased the development of persistent neuropathic pain (43.1% vs 63.3%; relative risk = .68; 95% confidence interval = .47-1.0). Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90-1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life. Our pilot trial successfully demonstrated feasibility and provided promising data for conducting further trials of intraoperative lidocaine infusions during breast cancer surgeries. Clinical trial number: NCT02240199 PERSPECTIVE: This article reports the findings of a pilot randomized, controlled trial evaluating the effects of perioperative pregabalin and intraoperative lidocaine infusions in patients undergoing breast cancer surgery. This trial demonstrated the feasibility of conducting a larger trial and provided promising data that these interventions may decrease the development of persistent pain.

Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial.

Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18-75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P < 0.001). No between-group differences were observed for compliance with medications, data completeness, loss to follow-up, or patient or research assistant satisfaction. More research assistant time per patient was spent collecting data in the traditional group (42.6 min [SD = 12.8] vs. 9.92 min [SD = 7.6]; P < 0.001); however, costs per patient were higher in the electronic group ($176.85 [SD = 2.90] vs. $16.33 [SD = 4.90]; P < 0.001). Conclusion: Electronic data collection is feasible for perioperative pain clinical trials. Additional trials, including different surgical populations, are needed to confirm our findings and optimize use of electronic data capture methods.

Contexte: La collecte électronique de données est de plus en plus disponible en tant que moyen de recueillir les données dans le cadre d'essais cliniques liés à la douleur; toutefois, l'efficacité et le coût de cette méthode, comparativement à la collecte de données traditionnelle, sont incertains.But: Évaluer la qualité des données, le respect du protocole, la satisfaction et les ressources requises dans le cadre de la collecte électronique de données (i.e. la transmission électronique par Internet) comparativement aux méthodes de collecte de données traditionnelles (c.-à.-d les cahiers papier et les entrevues téléphoniques) dans un essai randomisé contrôllé factoriel périopératoire.Méthodes: Cette étude était un essai contrôlé randomisé ouvert parallèle à deux volets. Des femmes (de 18 à 75 ans) subissant une chirurgie pour traiter un cancer du sein ont été réparties en deux groupes, soit celui de la collecte életronique de données et celui de la collecte traditionnelle de données. Elles ont ensuite répondu à des questionnaires liés à la douleur au départ, pendant la période post-opératoire et au bout de trois mois (NCT02240199).Résutats: Nous avons receuilli les données de 78 patientes randomisées à chaque point dans le temps : 38 patientes dans le groupe électronique et 40 patientes dans le groupe traditionnel. Le nombre de questions relatives aux données (ex.: données saisies de manière erronée) par patiente était plus élevé dans le groupe de données électroniques (4,92, É.-T. 4,67 comparativement à 1,88, É.-T. 1,51; p < 0,001). Aucune différence n'a été observée entre les groupes en ce qui concerne l'observance du traitement médicamenteux, l'exhaustivité des données, le nombre de patientes perdues de vue et la satisfaction des patientes ou des assistantes de recherche. Les assistants de recherche ont passé plus de temps par patiente pour recueillir les données dans le groupe traditionnel (42,6 minutes É.-T. 12,8 comparativement à 9,92 minutes É.-T. 76; p < 0,001); toutefois, le coût par patiente était plus élevé dans le groupe électronique (176,85 $ É.-T. 2,90 comparativement à 16,33 $ É.-T. 4,90; p < 0,001).Conclusion: La collecte électronique de données est réalisable dans le cadre d'essais cliniques portant sur la douleur périopératoire. Des essais supplémentaires, y compris auprès de différentes populations de patients chirurgicaux, sont nécessaires pour confirmer nos résultats et optimiser l'utilisation de méthodes éectroniques de saisie de données.

Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain.

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that trialists evaluating treatments for chronic pain should consider reporting 9 patient-important outcome domains. We examined the extent to which clinical trials evaluating the effect of opioids for chronic non-cancer pain (CNCP) report outcome domains recommended by IMMPACT. We systematically searched electronic databases for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate and independently, reviewers established the eligibility of each identified study and recorded all reported outcome domains from eligible trials. We conducted a priori regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains. Among 156 eligible trials, reporting of IMMPACT-recommended outcome domains was highly variable, ranging from 99% for pain to 7% for interpersonal functioning. Recently published trials were more likely to report the effect of treatment on physical functioning, emotional functioning, role functioning, sleep and fatigue, and participant disposition. Trials for which the corresponding author was from North America were more likely to report treatment effects on physical functioning and participant ratings of improvement and satisfaction with treatment. Trials published in higher impact journals were more likely to report treatment effects on emotional function, but less likely to report participant ratings of improvement and satisfaction with treatment. Most IMMPACT domains showed an increased rate of reporting over time, although many patient-important outcome domains remained unreported by over half of all trials evaluating the effects of opioids for CNCP.

Development of an algorithm to identify preoperative medical consultations using administrative data.

BACKGROUND: Preoperative consultation by internal medicine specialists may help improve the care of patients undergoing major surgery. Population-based administrative data are an efficient approach for studying these consultations at a population-level. However, administrative data in many jurisdictions lack specific codes to identify preoperative medical consultations, as opposed to consultations for nonoperative indications. OBJECTIVE: To develop an accurate claims-based algorithm for identifying preoperative medical consultations before major elective noncardiac surgery. RESEARCH DESIGN: We conducted a multicenter cross-sectional study in Ontario, Canada. Preoperative medical consultations identified by medical record abstraction were compared with those identified by linked administrative data (physician service claims, hospital discharge abstracts). SUBJECTS: We randomly selected 606 individuals, aged older than 40 years, who underwent elective intermediate-to-high-risk noncardiac surgery at 8 randomly selected hospitals between April 1, 2002 and March 31, 2004. RESULTS: Medical record abstraction identified preoperative medical consultations in 317 patients (52%). The optimal claims-based algorithm for identifying these consultations was a physician service claim for a consultation by a cardiologist, general internist, endocrinologist, geriatrician, or nephrologist within 4 months before the index surgical procedure. This algorithm had a sensitivity of 90% (95% confidence interval [CI]: 86-93), specificity of 92% (95% CI: 88-95), positive predictive value of 93% (95% CI: 89-95), and negative predictive value of 90% (95% CI: 86-93). CONCLUSIONS: A simple claims-based algorithm can accurately identify preoperative medical consultations before major elective noncardiac surgery. This algorithm may help enhance population-based evaluations of preoperative care, provided that the requisite linked administrative healthcare data are present.

A meta-analytic comparison of preoperative stress echocardiography and nuclear scintigraphy imaging.

In this meta-analysis we compared thallium imaging (TI) and stress echocardiography (SE) in patients at risk for myocardial infarction (MI) scheduled for elective noncardiac surgery. Two searches of published articles were used to identify relevant articles. We included all studies that stated the criteria for a positive test and detailed the frequency of postoperative MI and in-hospital death. Data were abstracted by two authors and captured preoperative patient characteristics, study design, blinding, and outcome adjudication. We defined a positive test as a test with a reversible defect and, where possible, quantified the size of the defects in each study. MI and/or death were the only postoperative outcomes of interest. We calculated the sensitivity, specificity, and likelihood ratio (LR) and, where possible, the Receiver Operating Characteristic (ROC) curve of a cardiac event in each study. The LR and ROC were combined by meta-analyses using the random effects model. Heterogeneity was assessed using the I2 test. The search revealed 68 studies of 10,049 patients. There were 25 SE studies and 50 TI studies. There were 7 studies with a direct comparison of the two methodologies. The quality of studies differed; routine screening for MI was used more frequently in SE studies (47.8% versus 21.2%; P = 0.008) and screening dictated treatment more often after TI (72.1%) than after SE (46.3%) (P = 0.027). The LR for SE was more indicative of a postoperative cardiac event than TI (LR, 4.09; 95% CI, 3.21-6.56 versus 1.83; 1.59-2.10; P = 0.001). This difference was attributable to fewer false-negative SEs. There was no difference in the cumulative ROC curves from qualitative studies (SE, 0.80; 95% CI, 0.76-.84 versus TI, 0.75; 95% CI, 0.70-081). Again, the LR for a negative SE was less (0.23; 95% CI, 0.17-0.32 versus 0.44; 95% CI, 0.36-0.54). A moderate-to-large defect, seen in 14% of patients, by either method predicts a postoperative cardiac event (LR, 8.35; 95% CI, 5.6-12.45). This meta-analysis possesses the statistical power to demonstrate that SE has better negative predicative characteristics than TI. A moderate-to-large perfusion defect by either SE or TI predicts postoperative MI and death. We conclude the SE is superior to TI in predicting postoperative cardiac events.

Prophylactic Diclectin reduces the incidence of postoperative vomiting.

BACKGROUND: Diclectin(R) (DCL) is an effective antiemetic used for relief of nausea and vomiting in pregnancy. It is unknown whether DCL is effective in the prevention of postoperative nausea and vomiting (PONV). METHODS: We conducted a randomized, stratified, double-blind placebo-controlled trial to examine the incidence of PONV in women undergoing elective laparoscopic tubal ligation in the day surgery setting. DCL (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) was administered orally the night before surgery, the morning of surgery, and upon hospital discharge. RESULTS: We enrolled 146 women in the trial, 127 of whom were included in the effectiveness analysis and 102 of whom were included in the efficacy analysis. We did not detect a difference in the incidence of nausea and vomiting in the first six hours postoperatively after adjusting for additional antiemetics administered. Patients receiving DCL as compared with placebo were significantly less likely to experience vomiting six to 24 hr postoperatively [5/59 (8.5%) vs 14/55 (25.4%), P < 0.017]. Treated patients tended to return to work earlier than those who received placebo (1.74 vs 3.7 days P = NS). CONCLUSION: Perioperative oral DCL reduces the incidence of postoperative vomiting in women undergoing elective laparoscopic tubal ligation, and may accelerate return to work.