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Background Patient expectations are important psychological determinants of health outcomes. The Treatment Expectation Questionnaire (TEX-Q) is a validated, multidimensional instrument for assessing treatment expectations; however, no Danish version has previously been available. This study aimed to translate and conduct an initial psychometric evaluation of a Danish version of the TEX-Q in patients undergoing spinal surgery. Methods The TEX-Q was translated using a structured forward–backward procedure in accordance with ISPOR guidelines, including expert review by clinicians from different professional backgrounds. Consecutive adult patients scheduled for spinal surgery at a university hospital were invited to participate. The initial psychometric evaluation followed established PROM reporting standards and included assessment of feasibility, internal consistency, test–retest reliability, floor and ceiling effects, and construct validity. Results The Danish TEX-Q demonstrated high comprehensibility and linguistic clarity, with mean item ratings ranging from 5.4 to 5.8 on a six-point Likert scale. Reliability varied across domains, with good internal consistency and test–retest reliability observed for most domains. Floor effects were negligible, while ceiling effects exceeded 15% in selected domains. Construct validity analyses showed no association between the TEX-Q total score and functional disability, while only limited domain-specific associations were observed, and a small but statistically significant positive association with quality of life. Conclusion The Danish version of TEX-Q was successfully translated and demonstrated promising initial psychometric properties in a population of patients undergoing spinal surgery. However, variability in reliability across domains warrants cautious interpretation of domain-level results. Further studies are needed to assess structural validity and confirm the psychometric properties of the instrument in larger and more diverse clinical populations.

IntroductionMultimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty.Methods and analysisRECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed at nine Danish hospitals. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Eligible participants undergoing total hip arthroplasty are randomised to:group A: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous placebo; group B: oral paracetamol 1000 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group C: oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group D: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg.Primary outcome is cumulative opioid consumption at 0–24 hours. Secondary outcomes are pain at rest, during mobilisation and during a 5 m walk and adverse events. Follow-up includes serious adverse events and patient reported outcome measures at 90 days and 1 year. A total of 1060 participants are needed to demonstrate a difference of 8 mg in 24-hour morphine consumption assuming an SD of 24.5 mg, a risk of type I errors of 0.0083 and a risk of type 2 errors of 0.2. Primary analysis will be a modified intention-to-treat analysis.With this trial we aim to verify recommendations for pain treatment after total hip arthroplasty, and investigate the role of dexamethasone as an analgesic adjuvant to paracetamol and ibuprofen.Ethics and disseminationThis trial is approved by the Region Zealand Committee on Health Research Ethics (SJ-799). Plans for dissemination include publication in peer-reviewed journals and presentation at scientific meetings.Trial registration numberNCT04123873.

Background Nerve block of the lateral femoral cutaneous nerve (LFCN) is a predominantly sensory block. It reduces pain following total hip arthroplasty (THA), but the non-responder rate is high. We hypothesized, that an increased volume of ropivacaine, would result in greater coverage of incisions used for THA. Methods We conducted a randomized, blinded trial in 20 healthy volunteers. Participants were randomized to receive bilateral LFCN-blocks with 8 mL ropivacaine 0.75% on the left side and 16 mL ropivacaine 0.75% on the right side, or vice versa. Allocation was blinded to both participants and outcome assessors. Before nerve block performance, incision lines for posterior and lateral THA approaches were depicted with invisible ultraviolet-paint, thereby securing sufficient blinding during outcome assessment. The blocked area was mapped using temperature and mechanical discrimination tests. Quadriceps muscle strength was monitored. Primary outcome was coverage of the posterior incision line assessed by temperature discrimination test. Results We found no difference in coverage of the posterior or lateral incision lines when comparing LFCN-blocks with 8 mL versus 16 mL of ropivacaine. The blocked area was significantly larger in the 16 mL group, assessed by both temperature discrimination test ( p  = 0.012) and mechanical discrimination test ( p  = 0.034). We observed no difference between groups regarding quadriceps muscle strength ( p  = 1.0). Conclusions A LFCN-block with increased volume of ropivacaine from 8 mL to 16 mL did not result in a greater coverage of posterior or lateral incision lines used for THA, but in a larger blocked sensory area. Trial registration Clinicaltrials.gov: NCT03138668 . Registered 3rd of May 2017.

AbstractObjectiveTo investigate the effects of one and two doses of intravenous dexamethasone in patients after total knee arthroplasty.DesignRandomised, blinded, placebo controlled trial with follow-up at 90 days.SettingFive Danish hospitals, September 2018 to March 2020.Participants485 adult participants undergoing total knee arthroplasty.InterventionA computer generated randomised sequence stratified for site was used to allocate participants to one of three groups: DX1 (dexamethasone (24 mg)+placebo); DX2 (dexamethasone (24 mg)+dexamethasone (24 mg)); or placebo (placebo+placebo). The intervention was given preoperatively and after 24 hours. Participants, investigators, and outcome assessors were blinded. All participants received paracetamol, ibuprofen, and local infiltration analgesia.Main outcome measuresThe primary outcome was total intravenous morphine consumption 0 to 48 hours postoperatively. Multiplicity adjusted threshold for statistical significance was P<0.017 and minimal important difference was 10 mg morphine. Secondary outcomes included postoperative pain.Results485 participants were randomised: 161 to DX1, 162 to DX2, and 162 to placebo. Data from 472 participants (97.3%) were included in the primary outcome analysis. The median (interquartile range) morphine consumptions at 0-48 hours were: DX1 37.9 mg (20.7 to 56.7); DX2 35.0 mg (20.6 to 52.0); and placebo 43.0 mg (28.7 to 64.0). Hodges-Lehmann median differences between groups were: −2.7 mg (98.3% confidence interval −9.3 to 3.7), P=0.30 between DX1 and DX2; 7.8 mg (0.7 to 14.7), P=0.008 between DX1 and placebo; and 10.7 mg (4.0 to 17.3), P<0.001 between DX2 and placebo. Postoperative pain was reduced at 24 hours with one dose, and at 48 hours with two doses, of dexamethasone.ConclusionTwo doses of dexamethasone reduced morphine consumption during 48 hours after total knee arthroplasty and reduced postoperative pain.Trial registrationClinicaltrials.gov NCT03506789.

Background Delirium is one of the most common complications among elderly hospitalized patients, postoperative patients and patients on intensive care units with a prevalence between 11 and 80%. Delirium is associated with higher morbidity and mortality. Reliable instruments are required to detect delirium at an early time point. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with high sensitivity and good specificity. However, there is currently no official translation after ISPOR guidelines of any Danish delirium assessment tools available. Thereby hampering the implementation of 2017 ESA-Guidelines on postoperative Delirium in the clinical routine. The aim of this study is to provide an official translation and evaluation of the Nu-DESC into Danish following the ISPOR process. Methods The Nu-DESC was translated after International Society for Pharmacoecomonics and Outcome Research (ISPOR) guidelines to Danish after permission of the original author, and is evaluated by medical staff and finally approved by the original author. Results All steps of the ISPOR guideline were consecutively followed, without any major problems. The evaluation of the Nu-DESC DK regarding its intelligibility and feasibility showed no statistically significant differences between nurses and medical doctors ratings. The translation was authorized and approved by the original author. Conclusion This study provides the Nu-DESC DK, an official Danish delirium screening instrument, which can detect all psychomotor types of delirium.

Background Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the statistical analysis plan for the primary publication to prevent outcome reporting bias and data-driven analysis results. Methods/design The PANSAID trial is a multicentre, randomised, controlled, parallel, four-group clinical trial comparing the beneficial and harmful effects of different doses and combinations of paracetamol and ibuprofen in patients having total hip arthroplastic surgery. Patients, caregivers, physicians, investigators, and statisticians are blinded to the intervention. The two co-primary outcomes are 24-h consumption of morphine and proportion of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and the proportion of patients with one or more adverse events within 24 h postoperatively. Discussion PANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting. Trial registration ClinicalTrials.org identifier: NCT02571361 . Registered on 7 October 2015.

Background Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No ‘gold standard’ exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA. Methods PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients and statisticians. Patients are randomised to four groups: (A) paracetamol 1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4 and ibuprofen 200 mg. The two co-primary outcomes are 24-h consumption of morphine and number of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and number of patients with one or more adverse events within 24 h postoperatively. Inclusion criteria are patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1–3; BMI >18 and <40 kg/m 2 ; women must not be pregnant; and provision of informed consent. Exclusion criteria are patients who cannot cooperate with the trial; participation in another trial; patients who cannot understand/speak Danish; daily use of strong opioids; allergy against trial medication; contraindications against ibuprofen; alcohol and/or drug abuse. A total of 556 eligible patients are needed to detect a difference of 10 mg morphine i.v. the first 24 h postoperatively with a standard deviation of 20 mg and a family wise type 1 error rate of 0.025 (two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of the four intervention groups. Discussion We started recruiting patients in December 2015 and expect to finish in September 2017. Data analysis will be from September 2017 to October 2017 and manuscript submission ultimo 2017. Trial registration EudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361 . Registered on 7 October 2015.