Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication.

OBJECTIVES: Addressing the challenges of ambulatory surgery involves balancing effective pain relief with minimizing the side effects of pain medication. Due to the heightened risk of opioid abuse, Helsinki University Hospital (Finland) has had a stringent oxycodone prescription policy. This policy prompts an exploration into whether ambulatory surgery patients experience severe post-surgical pain and whether an increase in prescribed opioids would cause elevation in adverse effects. METHODS: This prospective cohort study, with a 1-week follow-up, included 111 adult ambulatory surgery patients (orthopaedics, urology). The patients documented their pain levels within the first postoperative week (using a numerical rating scale [NRS] of 0-10) and pain medication intake up to two days postoperatively. Furthermore, they completed a questionnaire assessing their satisfaction with pain relief, medication-related adverse effects, and adherence to instructions. Medication intake was cross-referenced with the provided instructions and prescriptions. RESULTS: A notable 56% of patients reported experiencing intense pain (NRS ≥5) within a week following surgery. Of these, 52% received a single dose of slow-release oxycodone (5-20 mg) at discharge for use on the night of surgery. Predominantly prescribed pain medications included a combination of paracetamol and codeine (64%) or ibuprofen (62%). Satisfaction rates were high, with 87% expressing satisfaction with pain medication given at hospital discharge and 90% expressing contentment with the prescribed medication. The most common adverse effects were tiredness/grogginess (45%), sleep disturbances (38%), nausea (37%), and constipation (27%). Also, 24% of patients self-reported deviations from medication instructions. A comparison of self-reported and instructed medications revealed that 14% exceeded prescribed dosages, and 28% opted for preparations different from those prescribed. Notably, patients who self-reported deviations from instructions differed from those objectively deviating from instructions. CONCLUSIONS: Although 56% of patients had intense pain, the majority expressed satisfaction with the provided pain relief. Instances of non-adherence to medication instructions were prevalent, often going unnoticed by the patients themselves.

Case report and review: Angiosarcoma with thrombocytopenia after total hip arthroplasty.

Total hip arthroplasty (THA) is a common treatment for osteoarthritis and is also performed for other conditions, such as secondary arthritis due to developmental dysplasia of the hip. Various THA types may be complicated by osteolysis and an inflammatory pseudotumor due to an adverse reaction to metal debris. Rarely, THA has been associated with malignant tumors, but their causality remains unclear. In this case report, we describe a female patient with developmental dysplasia of the hip. She had undergone left metal-on-polyethylene THA, acetabular revision of the THA, and left total knee arthroplasty. In addition, she had a history of dyslipidemia and telangiectasia of the eyes, anemia, hiatal hernia, and pleuritis. A THA-associated mass (suspected to be a pseudotumor) had been detected during a previous hospital admission due to pleuritis. She was hospitalized due to swelling in her left lower limb, fatigue, and bruises. A clinical examination revealed anemia, thrombocytopenia, and growth of the suspected pseudotumor. Within 6 weeks, she presented with bleeding of the oral mucosa, hemoptysis, melena, severe thrombocytopenia that did not respond to treatment, elevated D-dimer and C-reactive protein levels, severe pain, increased osteolysis, and fractures around the THA. Infection or malignancy was suspected, but two trocar biopsies suggested an inflammatory pseudotumor. Since her anemia and thrombocytopenia were considered to have been caused by an inflammatory process within the suspected pseudotumor, her suspected pseudotumor and all THA components were surgically removed. However, she developed severe alveolar hemorrhaging and hypoxia and died 2 weeks after her surgery. Histopathological analysis of her surgical and autopsy samples revealed highly malignant angiosarcoma. Although individual cases of malignancies associated with THA have been reported, the literature lacks a clear association between THA and increased cancer risk. Most pseudotumors are non-malignant. The patient's case presented in this report exemplifies the challenges to the differential diagnosis of a THA-associated pseudotumor and rare angiosarcoma. Atypically rapid tumor growth, severe osteolysis, and deterioration in the general wellbeing suggest a malignant disease.

Testing of a predictive risk index for persistent postsurgical pain on patients undergoing total knee arthroplasty: A prospective cohort study.

BACKGROUND: We investigated whether a universal predictive risk index for persistent postsurgical pain (PPP) is applicable to patients who undergo total knee arthroplasty (TKA). METHODS: In this cohort study, 392 participants of a randomized study investigating the effects of anaesthesia methods and tourniquet use on TKA were divided into low-, moderate-, and high-risk groups for PPP, as suggested in the previous risk index study. Patients reported pain using the Oxford Knee Score pain subscale and Brief Pain Inventory-short form preoperatively and 3 and 12 months postoperatively. We compared the pain scores of the low- to moderate- and high-risk groups at respective time points and investigated changes in pain scores and the prevalence of PPP at 3 and 12 months after surgery. RESULTS: The high-risk group reported more pain 3 and 12 months after TKA than the low- to moderate-risk group. However, of seven variables, only a single difference reached the threshold for minimal clinical importance between the groups at 12 months. Additionally, at 12 months, the low- to moderate-risk group reported slightly worse improvements in three of seven pain variables than the high-risk group. Depending on the definition, the prevalence of PPP ranged from 2% to 29% in the low- to moderate-risk group and 4% to 41% in the high-risk group 12 months postoperatively. CONCLUSIONS: Although the investigated risk index might predict clinically important differences in PPP between the risk groups at 3 months after TKA, it seems poorly applicable for predicting PPP at 12 months after TKA. SIGNIFICANCE: Although many risk factors for persistent postsurgical pain after total knee arthroplasty have been identified, predicting the risk of this pain has remained a challenge. Results of the current study suggest that accumulation of previously presented modifiable risk factors might be associated with increased postsurgical pain at 3 months, but not at 12 months after total knee arthroplasty.

Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial.

BACKGROUND: Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. METHODS: We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS5 at 12 months. ETHICS AND DISSEMINATION: The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. TRIAL REGISTRATION: ClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.

Fat tissue is a poor predictor of 1 year outcomes after total knee arthroplasty: A secondary analysis of a randomized clinical trial.

BACKGROUND AND OBJECTIVE: Obesity may increase the risk of adverse events after total knee arthroplasty (TKA). Although body mass index (BMI) is commonly used in categorizing obesity, its accuracy is limited. Body fat percentage (BFP) might indicate adiposity status and predict arthroplasty-related outcomes better than BMI. We investigated whether BFP is predictive of TKA-related outcomes. METHODS: In this secondary analysis, BFP was measured preoperatively from 294 participants of a randomized trial that investigated the effects of tourniquet and anesthesia methods on TKA. Data concerning in-hospital assessments and events were collected. Knee range of motion (ROM) was measured, the Brief Pain Inventory-short form and Oxford Knee Score questionnaires were used to collect data on patient-reported pain and function, and the 15-dimensional health-related questionnaire was used to assess quality of life preoperatively and 3 and 12 months postoperatively. The patients reported satisfaction to TKA 3 and 12 months postoperatively. Data concerning infectious and thromboembolic events within 90 postoperative days and revision surgery, manipulation under anesthesia, and mortality within 1 year were collected. A separate post hoc analysis was performed for 399 participants to assess the effects of BMI on the respective outcomes. RESULTS: A 1-unit increase in BFP affected the ROM by -0.37° (95% confidence interval (CI) = -0.60 to -0.13) 12 months after surgery. BFP was not significantly associated with the operation time or adverse events. However, the number of most adverse events remained too low for adjusted analysis. A 1-unit increase in BMI increased the operation time by 0.57 min (95% CI = 0.10 to 1.04) and affected the ROM by -0.47° (95% CI = -0.74 to -0.20) 12 months postoperatively. Neither BFP nor BMI was significantly associated with acute pain, pain management, length of stay, or with pain, function, quality of life, or satisfaction to TKA at 12 months after surgery. CONCLUSIONS: BFP seems to be a poor predictor of in-hospital results and of patient-reported outcomes 1 year after TKA. TWITTER HANDLE: In this secondary analysis of a randomized trial, body fat percentage was poorly predictive of clinical outcomes during hospital stay and of patient-reported outcomes 1 year after TKA.

Validation of the Lean Healthcare Implementation Self-Assessment Instrument (LHISI) in the finnish healthcare context.

BACKGROUND: Lean management is growing in popularity in the healthcare sector worldwide, yet healthcare organizations are struggling with assessing the maturity of their Lean implementation and monitoring its change over time. Most existing methods for such assessments are time consuming, require site visits by external consultants, and lack frontline involvement. The original Lean Healthcare Implementation Self-Assessment Instrument (LHISI) was developed by the Center for Lean Engagement and Research (CLEAR), University of California, Berkeley as a Lean principles-based survey instrument that avoids the above problems. We validated the original LHISI in the context of Finnish healthcare. METHODS: The original HISI survey was sent over a secure organizational email system to the over 26,000 employees of the Hospital District of Helsinki and Uusimaa in March 2020. The data were randomly split with one part used to carry out an exploratory factor analysis (EFA), and the other for testing the resulting model using confirmatory factor analysis (CFA). RESULTS: A total of 6073 employees responded to the LHISI survey, for an overall response rate of 23%. The results indicated that the 43 items used in the original LHISI can be reduced to 25 items, and these items measure a five-dimensional model of the progress of Lean implementation: leadership, commitment, standard work, communication, and daily management system. In comparison with a single-factor model, the fit measures for the 5-factor model were better: smaller X2, larger comparative fit index (CFI), smaller root mean square error of approximation (RMSEA), and smaller standardized root mean square residual (SRMR). CONCLUSIONS: The 25 item LHISI is valid and feasible to use in the context of Finnish healthcare. The LHISI allows the organization to self-monitor the progress of its Lean implementation and provides the leadership with actionable knowledge to guide the path towards Lean maturity across the organization. Our findings encourage further studies on the adoption and validation of the LHISI in healthcare organizations worldwide.

Anesthesia Method, Tourniquet Use, and Persistent Postsurgical Pain after Total Knee Arthroplasty: A Prespecified Secondary Analysis of a Randomized Trial.

BACKGROUND: Persistent postsurgical pain after total knee arthroplasty is a common problem and a major reason for patient dissatisfaction. This secondary analysis aimed to investigate the effects of anesthesia (spinal vs. general) and tourniquet use on persistent pain after total knee arthroplasty. METHODS: In this secondary analysis of a previously presented parallel, single-center, randomized trial, 404 patients scheduled for total knee arthroplasty were randomized to spinal versus general anesthesia and no-tourniquet versus tourniquet groups. Patients assessed pain using the Brief Pain Inventory-short form preoperatively and 3 and 12 months postoperatively. The prespecified main outcome was the change in "average pain" measured with numerical 0 to 10 rating scale 1 yr postoperatively. The threshold for clinical importance between groups was set to 1.0. RESULTS: The change in average pain scores 1 yr postoperatively did not differ between the spinal and general anesthesia groups (-2.6 [SD 2.5] vs. -2.3 [SD 2.5], respectively; mean difference, -0.4; 95% CI, -0.9 to 0.1; P = 0.150). The no-tourniquet group reported a smaller decrease in the average pain scores than the tourniquet group (-2.1 [SD 2.7] vs. -2.8 [SD 2.3]; mean difference, 0.6; 95% CI, 0.1 to 1.1; P = 0.012). After 1 yr, the scores concerning the mean of four pain severity variables (numerical rating scale) decreased more in the spinal than in the general anesthesia group (-2.3 [SD 2.2] vs. -1.8 [SD 2.1]; mean difference, -0.5; 95% CI, -0.9 to -0.05; P = 0.029) and less in the no-tourniquet than in the tourniquet group (-1.7 [SD 2.3] vs. -2.3 [SD 2.0]; mean difference, 0.6; 95% CI, 0.2 to 1.0; P = 0.005). None of the differences in pain scores reached the threshold for clinical importance. CONCLUSIONS: The type of anesthesia (spinal vs. general) or tourniquet use has no clinically important effect on persistent postsurgical pain after total knee arthroplasty.

Classification of Electronic Health Record-Related Patient Safety Incidents: Development and Validation Study.

BACKGROUND: It is assumed that the implementation of health information technology introduces new vulnerabilities within a complex sociotechnical health care system, but no international consensus exists on a standardized format for enhancing the collection, analysis, and interpretation of technology-induced errors. OBJECTIVE: This study aims to develop a classification for patient safety incident reporting associated with the use of mature electronic health records (EHRs). It also aims to validate the classification by using a data set of incidents during a 6-month period immediately after the implementation of a new EHR system. METHODS: The starting point of the classification development was the Finnish Technology-Induced Error Risk Assessment Scale tool, based on research on commonly recognized error types. A multiprofessional research team used iterative tests on consensus building to develop a classification system. The final classification, with preliminary descriptions of classes, was validated by applying it to analyze EHR-related error incidents (n=428) during the implementation phase of a new EHR system and also to evaluate this classification's characteristics and applicability for reporting incidents. Interrater agreement was applied. RESULTS: The number of EHR-related patient safety incidents during the implementation period (n=501) was five-fold when compared with the preimplementation period (n=82). The literature identified new error types that were added to the emerging classification. Error types were adapted iteratively after several test rounds to develop a classification for reporting patient safety incidents in the clinical use of a high-maturity EHR system. Of the 427 classified patient safety incidents, interface problems accounted for 96 (22.5%) incident reports, usability problems for 73 (17.1%), documentation problems for 60 (14.1%), and clinical workflow problems for 33 (7.7%). Altogether, 20.8% (89/427) of reports were related to medication section problems, and downtime problems were rare (n=8). During the classification work, 14.8% (74/501) of reports of the original sample were rejected because of insufficient information, even though the reports were deemed to be related to EHRs. The interrater agreement during the blinded review was 97.7%. CONCLUSIONS: This study presents a new classification for EHR-related patient safety incidents applicable to mature EHRs. The number of EHR-related patient safety incidents during the implementation period may reflect patient safety challenges during the implementation of a new type of high-maturity EHR system. The results indicate that the types of errors previously identified in the literature change with the EHR development cycle.

Use of a Tourniquet and Spinal Anesthesia Increases Satisfactory Outcomes After Total Knee Arthroplasty: A Randomized Study.

BACKGROUND: Total knee arthroplasty (TKA) is usually performed successfully with or without a tourniquet and under spinal anesthesia (SA) or general anesthesia (GA). However, 10% to 34% of patients experience dissatisfaction and pain after TKA. We aimed to compare the effects of tourniquet use and SA or GA on TKA outcomes. METHODS: We randomly assigned 404 patients to 4 study groups: SA without a tourniquet (NT/SA), SA with a tourniquet (T/SA), GA without a tourniquet (NT/GA), and GA with a tourniquet (T/GA). The primary outcome was the change in the Oxford Knee Score (OKS) at 1 year postoperatively. Secondary outcomes included a satisfactory TKA outcome assessed using the OKS minimal important change (MIC) and OKS patient acceptable symptom state (PASS), adverse events, and quality of life using the 15-dimensional health-related quality of life tool. RESULTS: At 1 year, the OKS was obtained for 381 patients. In the 2-group comparisons, the tourniquet did not affect the OKS improvement. The SA group had more substantial improvement in the OKS than the GA group (16.21 compared with 14.08 a mean difference of 2.13; 95% confidence interval [CI], 0.55 to 3.71; p = 0.008). In the 4-group comparisons, the T/SA group had more substantial improvements in the OKS than the NT/GA group (16.87 compared with 13.65, a mean difference of 3.2; 95% CI, 0.28 to 6.17; p = 0.026). The SA group reached the OKS MIC more frequently than the GA group (91.7% compared with 81.7%; odds ratio [OR] = 2.49 [95% CI, 1.32 to 4.69]; p = 0.005). The SA group also reached the OKS PASS more frequently than the GA group (86.0% compared with 75.7%; OR = 2.00 [95% CI, 1.18 to 3.39]; p = 0.010). The T/SA group had significantly more patients reaching the OKS MIC than the NT/GA group (95.7% compared with 79.6%; p = 0.005) and more patients reaching the OKS PASS than the NT/GA group (92.6% compared with 74.5%; p = 0.004). No differences were seen with respect to adverse events in any comparisons. CONCLUSIONS: The tourniquet had no detrimental effects on the outcomes of TKA. SA had a positive effect on the OKS. The use of SA combined with a tourniquet resulted in the best improvement in OKS and the highest proportion of satisfactory outcomes with TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Intravenous patient-controlled analgesia vs nurse administered oral oxycodone after total knee arthroplasty: a retrospective cohort study.

OBJECTIVES: Severe post-operative pain is common after total knee arthroplasty. Patient-controlled analgesia is an alternative method of pain management, whereby a patient administers his or her own pain medication. Patients seem to prefer this method over nurse-administered analgesia. However, it remains unclear whether patients using patient-controlled analgesia devices use higher or lower doses of opioids compared to patients treated with oral opioids. METHODS: This retrospective study examined 164 patients undergoing total knee arthroplasty. Post-operatively, 82 patients received oxycodone via intravenous patient-controlled analgesia devices, while the pain medication for 82 patients in the control group was administered by nurses. The main outcome measure was the consumption of intravenous opioid equivalents within 24 h after surgery. Secondary outcome measures were the use of anti-emetic drugs and the length of stay. Furthermore, we evaluated opioid-related adverse event reports. RESULTS: The consumption of opioids during the first 24 h after surgery and the use of anti-emetic drugs were similar in both groups. The median opioid dose of intravenous morphine equivalents was 41.1 mg (interquartile range (IQR): 29.5-69.1 mg) in the patient-controlled analgesia group and 40.5 mg (IQR: 32.4-48.6 mg) in the control group, respectively. The median length of stay was 2 days (IQR: 2-3 days) in the patient-controlled analgesia group and 3 days (IQR: 2-3 days) in the control group (p=0.02). The use of anti-emetic drugs was similar in both groups. CONCLUSIONS: The administration of oxycodone via intravenous patient-controlled analgesia devices does not lead to increased opioid or anti-emetic consumptions compared to nurse-administered pain medication after total knee arthroplasty. Patient-controlled analgesia might lead to shortened length of stay.

Effects of anaesthesia method and tourniquet use on recovery following total knee arthroplasty: a randomised controlled study.

BACKGROUND: We investigated the effects of spinal and general anaesthesia and surgical tourniquet on acute pain and early recovery after total knee arthroplasty (TKA). METHODS: Patients (n=413) were randomised to four parallel groups: spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet. The primary outcome was patient-controlled i.v. oxycodone consumption over 24 postoperative hours. RESULTS: Results from 395 subjects were analysed. Median i.v. oxycodone consumption did not differ between the four groups (spinal anaesthesia without [36.6 mg] and with tourniquet [38.0 mg], general anaesthesia without [42.3 mg] and with tourniquet [42.5 mg], P=0.42), between spinal (37.7 mg) and general anaesthesia (42.5 mg) groups (median difference -3.1, 95% confidence interval [CI] -7.4 to 1.2, P=0.15) and between tourniquet and no-tourniquet groups (40.0 vs 40.0 mg, median difference -0.8, CI -5.1 to 3.5, P=0.72). Vomiting incidence was higher with spinal than with general anaesthesia (21% [42/200] vs 13% [25/194], CI 1.05 to 3.1, P=0.034). The mean haemoglobin decrease was greater without than with tourniquet (-3.0 vs -2.5 g dl-1, mean difference -0.48, CI -0.65 to -0.32, P<0.001). No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay. CONCLUSIONS: For TKA, spinal and general anaesthesia with or without tourniquet did not differ in 24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay. Vomiting incidence was higher in the spinal than in the general anaesthesia group. Tourniquet use caused smaller decreases in haemoglobin levels. CLINICAL TRIAL REGISTRATION: EudraCT 2016-002035-15.

Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

INTRODUCTION: Total knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regimen and assess the effect of a tourniquet on the patient's recovery following total knee arthroplasty. METHODS AND ANALYSIS: This study is a randomised, controlled, parallel-group, four-arm study comparing spinal and general anaesthesia with and without a tourniquet in 400 patients undergoing fast-track total knee arthroplasty, with a 12-month follow-up. The primary outcome is cumulative intravenous oxycodone consumption by patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative nausea and vomiting, the length of hospital stay, the duration of the surgery, blood loss, demand for surgical unit resources, complications, readmissions, postoperative knee function, range of motion, health-related quality of life, prolonged pain and mortality. ETHICS AND DISSEMINATION: This study's protocol is in accordance with the declaration of Helsinki. The results of this study will be disseminated in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03364088; Pre-results.