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Background: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. Methods: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1–3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. Discussion: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. Trial registration: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021). [ABSTRACT FROM AUTHOR]

Background: There remain few efficacious treatments for bipolar depression, which dominates the course of bipolar disorder (BD). Despite multiple studies reporting associations between depression and cerebral blood flow (CBF), little is known regarding CBF as a treatment target, or predictor and/or indicator of treatment response, in BD. Nitrous oxide, an anesthetic gas with vasoactive and putative antidepressant properties, has a long history as a neuroimaging probe. We undertook an experimental medicine paradigm, coupling in‐scanner single‐session nitrous oxide treatment of bipolar depression with repeated measures of CBF. Methods: In this double‐blind randomized controlled trial, 25 adults with BD I/II and current treatment‐refractory depression received either: (1) nitrous oxide (20 min at 25% concentration) plus intravenous saline (n = 12), or (2) medical air plus intravenous midazolam (2 mg total; n = 13). Study outcomes included changes in depression severity (Montgomery‐Asberg Depression Rating Scale scores, primary) and changes in CBF (via arterial spin labeling magnetic resonance imaging). Results: There were no significant between‐group differences in 24‐h post‐treatment MADRS change or treatment response. However, the nitrous oxide group had significantly greater same‐day reductions in depression severity. Lower baseline regional CBF predicted greater 24‐h post‐treatment MADRS reductions with nitrous oxide but not midazolam. In region‐of‐interest and voxel‐wise analyses, there was a pattern of regional CBF reductions following treatment with midazolam versus nitrous oxide. Conclusions: Present findings, while tentative and based on secondary endpoints, suggest differential associations of nitrous oxide versus midazolam with bipolar depression severity and cerebral hemodynamics. Larger studies integrating neuroimaging targets and repeated nitrous oxide treatment sessions are warranted. [ABSTRACT FROM AUTHOR]

Background: Obstructive sleep apnea (OSA) is associated with neurocognitive impairment – a known risk factor for postoperative delirium. However, it is unclear whether OSA increases the risk of postoperative delirium and whether treatment is protective. The objectives of this study were to identify OSA with a home sleep apnea test (HSAT) and to determine whether auto-titrating positive airway pressure (APAP) reduces postoperative delirium in older adults with newly diagnosed OSA undergoing elective hip or knee arthroplasty. Methods: We conducted a multi-centre, randomized controlled trial at three academic hospitals in Canada. Research ethics board approval was obtained from the participating sites and informed consent was obtained from participants. Inclusion criteria were patients who were ≥ 6 0 years and scheduled for elective hip or knee replacement. Patients with a STOP-Bang score of ≥ 3 had a HSAT. Patients were defined as having OSA if the apnea–hypopnea index was ≥ 10/h. These patients were randomized 1:1 to either: 1) APAP for 72 h postoperatively or until discharge, or 2) routine care after surgery. The primary outcome was postoperative delirium, assessed twice daily with the Confusion Assessment Method for 72 h or until discharge or by chart review. The secondary outcome measures included length of stay, and perioperative complications occurring within 30 days after surgery. Results: Of 549 recruited patients, 474 completed a HSAT. A total of 234 patients with newly diagnosed OSA were randomized. The mean age was 68.2 (6.2) years and 58.6% were male. Analysis was performed on 220 patients. In total, 2.7% (6/220) patients developed delirium after surgery: 4.4% (5/114) patients in the routine care group, and 0.9% (1/106) patients in the treatment group (P = 0.21). The mean length of stay for the APAP vs. the routine care group was 2.9 (2.9) days vs. 3.5 (4.5) days (P = 0.24). On postoperative night 1, 53.5% of patients used APAP for 4 h/night or more, this decreased to 43.5% on night 2, and 24.6% on night 3. There was no difference in intraoperative and postoperative complications between the two groups. Conclusions: We had an unexpectedly low rate of postoperative delirium thus we were unable to determine if postoperative delirium was reduced in older adults with newly diagnosed OSA receiving APAP vs. those who did not receive APAP after elective knee or hip arthroplasty. Trial registration: This trial was retrospectively registered in clinicaltrials.gov NCT02954224 on 03/11/2016. [ABSTRACT FROM AUTHOR]

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Background: Delirium is a common problem that occurs in 5-50% of elderly individuals following surgery. Patients who develop delirium after surgery are at increased risk for serious complications. Recent studies suggest that patients with obstructive sleep apnea (OSA), a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. OSA is more common in elderly individuals but is often undiagnosed. Identification and treatment of unrecognized OSA may reduce the incidence of postoperative delirium. However, few studies have investigated the effect of perioperative treatment of OSA to prevent postoperative delirium. Methods: This multi-centre randomized controlled trial will enrol 634 elderly patients undergoing elective hip/knee replacement surgery. The study has been approved by the Research Ethics Boards of the three participating institutions. Patients will be screened with the STOP-Bang questionnaire. Those with a score of 3 or greater will have a portable home sleep study using the ApneaLink™ Air device. Patients identified to have OSA will be randomized to 1) Auto-titrating continuous positive airway pressure (APAP) applied during sleep for 72 h after surgery or until discharge if they are discharged before 72 h or 2) Control group - routine care, no APAP. All patients will be evaluated for delirium for 72 h after surgery or until discharge if they are discharged before 72 h. The primary outcome is the occurrence of delirium - assessed twice daily using the Confusion Assessment Method for 72 h or until discharge if the hospital stay is <72 h. Discussion: Delirium is associated with increased morbidity and mortality, and higher healthcare costs. With the aging population, the incidence of postoperative delirium will likely increase as the number of elderly individuals undergoing surgery rises. The results of our study will be published in a peer-reviewed journal and presented at local and international medical conferences. Our study findings may lead to improved surgical outcomes, enhanced patient safety and reduced healthcare costs. Trial registration: This study was retrospectively registered at clinicaltrials.gov NCT02954224 on November 3, 2016. [ABSTRACT FROM AUTHOR]

Hip replacement surgery can be painful; postoperative analgesia is crucial for comfort and to facilitate recovery. Regional anaesthesia can reduce pain and postoperative opioid requirements. The role of ultrasound-guided suprainguinal fascia iliaca block for analgesia after elective total hip arthroplasty is not well defined. This randomised trial evaluated its analgesic efficacy. Consenting participants (134) scheduled for elective primary total hip arthroplasty under spinal anaesthesia were randomly allocated to receive ultrasound-guided fascia iliaca block with ropivacaine 0.5% or sham block with saline. The primary outcome was opioid consumption in the first 24 h after surgery. Additional outcomes included pain scores at 4, 8, 12, and 16 h, opioid-related side-effects (nausea, vomiting, pruritis), ability to perform physiotherapy on the first postoperative day, and physiotherapist-assessed quadriceps weakness. There were no significant differences in 24-h opioid consumption (block vs sham block, mean difference −3.2 mg oral morphine equivalent, 95% confidence interval −15.3 to 8.1 mg oral morphine equivalent, P =0.55) or any other prespecified outcomes. In patients undergoing primary total hip arthroplasty, ultrasound-guided suprainguinal fascia iliaca block with ropivacaine did not confer a significant opioid-sparing effect compared with sham block. There were no differences in other secondary outcomes including pain scores, opioid-related side-effects, or ability to perform physiotherapy on the first postoperative day. www.clinicaltrials.gov (NCT03069183). [ABSTRACT FROM AUTHOR]

Background: Efforts to prolong interscalene block (ISB) analgesia include the use of local anaesthetic adjuvants such as dexamethasone. Previous work showing prolonged block duration suggests that both perineural and intravenous (i.v.) routes can both prolong analgesia. The superiority of either route is controversial given the design of previous studies. As perineural dexamethasone is an off-label use, anaesthesiologists should be fully informed of the clinical differences, if any, on block duration. This study was designed to test whether perineural vs i.v. dexamethasone administration are equivalent.Methods: We randomised 182 eligible patients scheduled for arthroscopic shoulder surgery to receive low-dose ISB (0.5% ropivacaine 5 ml) with perineural or i.v. dexamethasone 4 mg. Subjects, anaesthesiologists, and research personnel were blinded. All subjects also received a standardised general anaesthetic and multimodal analgesia. The primary outcome was duration of analgesia analysed as an equivalence outcome (2 h equivalency margin) using the two one-sided test (TOST) method.Results: For the primary outcome, duration of analgesia, and perineural and i.v. administration of dexamethasone were not equivalent. The upper and lower bounds of the 90% confidence interval were 1 h (P=0.12) and -2.5 h (P=0.01), respectively. The observed difference in mean block duration was not clinically relevant (0.75 h longer for i.v. dexamethasone). There were no other clinically significant differences between groups.Conclusion: In the context of low-volume ISB with ropivacaine, perineural and i.v. dexamethasone were not equivalent in terms of their effects on block duration. However, there were no clinically significant differences in outcomes, and there is no advantage of perineural over intravenous dexamethasone. WWW.CLINICALTRIALS.Gov Registration: NCT02322242. [ABSTRACT FROM AUTHOR]