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In a phase 1–2 dose-escalation trial involving adults with ALS due to SOD1 mutations who received intrathecal tofersen (an antisense oligonucleotide) or placebo, the levels of mutant SOD1 in the CSF were 33 percentage points lower in the highest-dose tofersen group than in the placebo group.

BackgroundLaparoscopic liver surgery has undergone substantial advancements over the past few decades, and the key to this improvement has been an improved understanding of liver anatomy, radiologic imaging, and advancements in anesthesia and postoperative care. This study aimed to compare postoperative opioid consumption in patients receiving intrathecal morphine plus low-dose bupivacaine versus those receiving intravenous morphine.MethodsIn this randomized controlled trial, 40 patients were enrolled and randomly assigned to two groups, of which one received 0.2 mg intrathecal morphine plus 0.25% Marcaine in a total volume of 4 mL and the other received intravenous morphine intraoperatively. Pain relief and patient satisfaction were evaluated using the visual analog scale. Intraoperative blood loss was measured at the end of the surgery while morphine consumption was measured by monitoring intravenous patient-controlled morphine at 12, 24, 36, and 48 h postoperatively. Treatment efficacy and complications were documented.ResultsMorphine consumption was significantly different in both groups at all time points, although the pain score did not show any difference. Shoulder pain, a common adverse effect of laparoscopic surgery, was significantly lower in the intrathecal group (25% vs. 75%). Blood loss and patient satisfaction were not different between the groups. However, the intrathecal group showed a significantly higher incidence of intraoperative hypotension.ConclusionIntrathecal morphine with bupivacaine can be used effectively for managing acute post-LLR pain.Thai Clinical trial registryTCTR20211015004.

Background Orthopaedic surgeries are among the most painful procedures. By adding low-dose morphine to intrathecal bupivacaine for spinal anaesthesia, the analgesic effect can be improved. The objeсtive of the study was tо compare the efficacy and safety of lоw-dоse (0.1 mg аnd 0.2 mg) intrаtheсаl mоrphine (ITM). Methods А prоspeсtive rаndоmised study was соnduсted at the Hоspitаl оf Trаumаtоlоgy аnd Оrthоpaediсs, Riga, Latvia (February 2020 tо May 2021) and enrolled 90 patients undergoing primary hip arthroplasty. All subjects were randomised intо three study grоups, using the online tool оn www.randomiser.org . Treatment groups were allocated to intrathecal morphine (0.1 mg and 0.2 mg) in addition to bupivacaine (15 to 18 mg). The primary outcome was postoperative pain intensity among the three study groups within 24 hours by NRS. The secondary outcomes: pain at rest 4 h, 7 h, 12 h, 24 h postoperatively, respiratory rate, SpО2, morphine соnsumptiоn, оxygen supply, opioid-related аdverse reасtiоns within 24 hours postoperatively. Dаtа were аnаlysed using R version 4.2.0, applying the Mann-Whitney test, Pearson’s chi-squared test, Fisher’s exact test, Friedman test, Wilcoxon test. Results The primary outcome in the control, ITM 0.1 mg, ITM 0.2 mg groups, respectively: 2.56, 0.87, 0.28 ( p < 0.001). The secondary outcomes in the control, ITM 0.1 mg, ITM 0.2 mg group, respectively: pain scores 4h – 1.21, 0.48, 0.17 ( p = 0.068); 7 h – 2.62, 1.00, 0.17 ( p < 0.001); 12 h – 3.08, 0.65, 0.37 ( p < 0.001); 24 h – 2.50, 1.20, 0.41 ( p < 0.001); rescue medication requests (incidence, %): 77%, 16.7%, 13.3% ( p < 0.001); mean respiratory rate (breath/min) – 15.2; 15.2 ( p > 0.05); mean SpO2 (%): 96.7%; 95.7%; 96.07%. Significant adverse effects: pruritus in ITM 0.2 mg group (23% of subjects, p < 0.001). Conclusions Adult patients undergoing THA under spinal anaesthesia with bupivacaine and 0.2 mg morphine had superior analgesia to patients who received spinal analgesia with bupivacaine or bupivacaine and 0.1 mg morphine. Trial registration Study ID ISRCTN37212222; 20/04/2022 (registered retrospectively)

Background Thoracoscopic surgical techniques continue to advance, yet the intensity of postoperative pain remains significant, impeding swift patient recovery. This study aimed to evaluate the differences in postoperative pain and recuperation between patients receiving intrathecal morphine paired with low-dose bupivacaine and those administered general anesthesia exclusively. Methods This randomized controlled trial enrolled 100 patients, who were allocated into three groups: Group M (5 μg/kg morphine intrathecal injection), Group B (5 μg/kg morphine combined with bupivacaine 3 mg intrathecal injection) and Group C (intrathecal sham injection). The primary outcome was the assessment of pain relief using the Numeric Rating Scale (NRS). Additionally, intraoperative remifentanil consumption was quantified at the end of the surgery, and postoperative opioid use was determined by the number of patient-controlled analgesia (PCIA) compressions at 48 h post-surgery. Both the efficacy of the treatments and any complications were meticulously recorded. Results Postoperative NRS scores for both rest and exercise at 6, 12, 24, and 48 h were significantly lower in groups M and B than in group C ( P <0.05). The intraoperative remifentanil dosage was significantly greater in groups M and C than in group B ( P <0.05), while there was no significant difference between groups M and C ( P >0.05). There was no significant difference in intraoperative propofol dosage across all three groups ( P >0.05). Postoperative dosages of both sufentanil and Nonsteroidal anti‐inflammatory drugs (NSAIDs) were significantly less in groups M and B compared to group C ( P <0.05). The time of first analgesic request was later in both groups M and B than in group C ( P <0.05). Specific and total scores were elevated at 2 days postoperative when compared to scores at 1 day for all groups ( P <0.05). Furthermore, at 1 day and 2 days postoperatively, both specific scores and total scores were higher in groups M and B compared to group C ( P <0.05). Conclusion Intrathecal administration of morphine combined with bupivacaine has been shown to effectively ameliorate acute pain in patients undergoing thoracoscopic surgery. Trial registration The trial was registered on ClinicalTrials.gov: ChiCTR2200058544, registered 10/04/2022.

IntroductionThere are major differences between legal and medical approaches to informed consent. Medically, consent is obtained prospectively for an intended procedure, to inform the patient of choices, risks and benefits, and to manage expectations. Legally, consent is reviewed retrospectively, usually following unmet expectations and/or the occurrence of complications. Recent legal cases relating to clinical negligence define the establishment of causation and breach of duty related to informed consent. However, there is no prospective evidence to validate the current judicial perspectives on causation and thus clinical negligence. The aim of this randomised controlled trial (RCT) is to investigate whether variations in consenting processes for the same procedure lead to changes in patient decision-making related to consent for that procedure.Methods and analysisThe Risks In Spinal Consenting for Surgery trial is a single-centre, non-inferiority RCT, where 220 patients, aged over 18 years, receiving an elective, day case spinal injection, will be randomised to either a ‘legally styled’ consent form with 55 risks identified in the world literature, or a ‘medically styled’ consent form with the 13 serious or most common risks usually quoted by reference to specialist society guidelines. Following explanation of the medical reasons for considering an injection therapy and consent to the trial, participants will be randomly allocated to one of two groups (1:1). The patients are then given the opportunity to discuss any concerns relating to the procedure and/or risks with a single specialist practitioner. The primary outcome will be rates of consent withdrawal due to the risks explained. Secondary outcomes include scores from the State-Trait Anxiety Inventory, Visual Analogue Scale, EuroQol 5-dimension questionnaire and Oswestry Disability Index.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. This study is approved by the Health Research Authority: REC 16/SC/0510.Trial registration number ISRCTN67513618; Pre-results.

BackgroundIntrathecal drug delivery (IDD) is a well-established treatment modality for refractory chronic pain. Intrathecal catheter-tip granuloma (ICTG) formation is a known possible complication of opiate IDD and is likely triggered by mast cell degranulation. The use of low concentration and dosage of opioids that do not induce mast cell degranulation has been advised to mitigate the risk of ICTG formation.Case presentationA patient in their 50s with history of multiple lumbar spine surgeries and refractory low back pain who was treated with IDD developed an initial ICTG while receiving intrathecal hydromorphone and bupivacaine. The patient’s catheter was thus replaced and repositioned. The pump was also replaced due to repeat motor stall, and the infusate was changed from hydromorphone with bupivacaine to low-dose fentanyl with bupivacaine. Five years later, the patient developed myelopathic symptoms, and on imaging a new mass believed to be an ICTG was detected at the new thoracic catheter tip location. The patient was placed on normal saline infusion for 4 months before system explant, with some improvement of symptoms.ConclusionsICTG formation is uncommon but can be a devastating complication of IDD if not properly diagnosed in a timely fashion. Repeat ICTG has only been documented twice in the literature, and ICTG with low dose fentanyl in combination with bupivacaine has not been reported. Despite using regimens and techniques to reduce the risk of ICTG formation, one must judiciously surveil their patients for the dreaded ICTG complication.

An ongoing U.S. outbreak of invasive fungal infections (IFI) has been linked to methylprednisolone used for injection. In this report from Tennessee, the initial characteristics of 66 patients with presumed IFI associated with this event are presented. More than 500,000 epidural glucocorticoid injections are administered in the United States each year in the Medicare population alone. 1 Complications after epidural glucocorticoid injections are rare; when complications do occur, the most common are epidural abscesses and meningitis due to bacterial pathogens, with the complications frequently occurring in immunosuppressed persons. 2 – 6 Infectious disease outbreaks associated with epidural glucocorticoid injections have rarely been reported. 3 , 5 , 7 Fungal infections of the central nervous system are also uncommon and typically occur in immunosuppressed persons. Outbreaks of fungal meningitis after epidural or spinal injection are extremely rare; an outbreak of Exophiala dermatitidis meningitis in . . .

Cerebrospinal fluid (CSF) flowing through periarterial spaces is integral to the brain’s mechanism for clearing metabolic waste products. Experiments that track tracer particles injected into the cisterna magna (CM) of mouse brains have shown evidence of pulsatile CSF flow in perivascular spaces surrounding pial arteries, with a bulk flow in the same direction as blood flow. However, the driving mechanism remains elusive. Several studies have suggested that the bulk flow might be an artifact, driven by the injection itself. Here, we address this hypothesis with new in vivo experiments where tracer particles are injected into the CM using a dual-syringe system, with simultaneous injection and withdrawal of equal amounts of fluid. This method produces no net increase in CSF volume and no significant increase in intracranial pressure. Yet, particle-tracking reveals flows that are consistent in all respects with the flows observed in earlier experiments with single-syringe injection.

Spinal muscular atrophy (SMA) is a progressive neuromuscular disorder characterized by progressive motor function loss and skeletal muscular atrophy. Nusinersen, an antisense oligonucleotide, is the first FDA-approved therapy to achieve a significant milestone in SMA management. However, its high molecular weight requires intrathecal administration, posing challenges for clinical implementation. This study aimed to identify factors associated with postprocedural pain following repeated CT-guided transforaminal nusinersen injection in non-ambulatory patients with SMA. This single-center retrospective study evaluated 34 patients who underwent a total of 290 procedures. Postprocedural pain occurred in 49.3% of cases. Factors influencing postprocedural pain included needle angle with vertical and horizontal lines, prophylactic pain control, and number of CT scans (p < 0.05). In patients experiencing postprocedural pain, the needle angle with vertical and horizontal lines emerged as significant variables, with a beta coefficient (standard error) of 0.034 (0.011) (p < 0.05). Needle angle was an important predictor of postprocedural pain.

Last year, invasive fungal infections were identified in association with injections of contaminated methylprednisolone from a compounding pharmacy. In this report, the epidemiology of the outbreak is presented from its identification in September 2012 through mid-2013. There has been no systematic surveillance in the United States for adverse events that occur after glucocorticoid injections for the treatment of chronic musculoskeletal pain, but infection is a known, although probably rare, risk documented in the medical literature. 1 – 6 Infections that develop after a procedure are usually bacterial 2 , 7 – 10 ; fungal infections are extremely rare. 11 – 14 We present data on a multistate outbreak of fungal meningitis and other infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy and describe the public health response to the outbreak. Methods Index Patient and Early . . .