Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study.

BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy. METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries. RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures. CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

Chronic postsurgical pain: A European survey.

BACKGROUND: Chronic postsurgical pain (CPSP) is a clinical problem, and large prospective studies are needed to determine its incidence, characteristics, and risk factors. OBJECTIVE: To find predictive factors for CPSP in an international survey. DESIGN: Observational study. SETTING: Multicentre European prospective observational trial. PATIENTS: Patients undergoing breast cancer surgery, sternotomy, endometriosis surgery, or total knee arthroplasty (TKA). METHOD: Standardised questionnaires were completed by the patients at 1, 3, and 7 days, and at 1, 3, and 6 months after surgery, with follow-up via E-mail, telephone, or interview. MAIN OUTCOME MEASURE: The primary goal of NIT-1 was to propose a scoring system to predict those patient likely to have CPSP at 6 months after surgery. RESULTS: A total of 3297 patients were included from 18 hospitals across Europe and 2494 patients were followed-up for 6 months. The mean incidence of CPSP at 6 months was 10.5%, with variations depending on the type of surgery: sternotomy 6.9%, breast surgery 7.4%, TKA 12.9%, endometriosis 16.2%. At 6 months, neuropathic characteristics were frequent for all types of surgery: sternotomy 33.3%, breast surgery 67.6%, TKA 42.4%, endometriosis 41.4%. One-third of patients experienced CPSP at both 3 and 6 months. Pre-operative pain was frequent for TKA (leg pain) and endometriosis (abdomen) and its frequency and intensity were reduced after surgery. Severe CPSP and a neuropathic pain component decreased psychological and functional wellbeing as well as quality of life. No overarching CPSP risk factors were identified. CONCLUSION: Unfortunately, our findings do not offer a new CPSP predictive score. However, we present reliable new data on the incidence, characteristics, and consequences of CPSP from a large European survey. Interesting new data on the time course of CPSP, its neuropathic pain component, and CPSP after endometriosis surgery generate new hypotheses but need to be confirmed by further research. TRIAL REGISTRATION: clinicaltrials.gov ID: NCT03834922.

Fever and hypothermia represent two populations of sepsis patients and are associated with outside temperature.

BACKGROUND: Fever and hypothermia have been observed in septic patients. Their influence on prognosis is subject to ongoing debates. METHODS: We did a secondary analysis of a large clinical dataset from a quality improvement trial. A binary logistic regression model was calculated to assess the association of the thermal response with outcome and a multinomial regression model to assess factors associated with fever or hypothermia. RESULTS: With 6542 analyzable cases we observed a bimodal temperature response characterized by fever or hypothermia, normothermia was rare. Hypothermia and high fever were both associated with higher lactate values. Hypothermia was associated with higher mortality, but this association was reduced after adjustment for other risk factors. Age, community-acquired sepsis, lower BMI and lower outside temperatures were associated with hypothermia while bacteremia and higher procalcitonin values were associated with high fever. CONCLUSIONS: Septic patients show either a hypothermic or a fever response. Whether hypothermia is a maladaptive response, as indicated by the higher mortality in hypothermic patients, or an adaptive response in patients with limited metabolic reserves under colder environmental conditions, remains an open question. Trial registration The original trial whose dataset was analyzed was registered at ClinicalTrials.gov (NCT01187134) on August 23, 2010, the first patient was included on July 1, 2011.

'Desire for more analgesic treatment': pain and patient-reported outcome after paediatric tonsillectomy and appendectomy.

BACKGROUND: Insufficiently treated pain after paediatric appendectomy and tonsillectomy is frequent. We aimed to identify variables associated with poor patient-reported outcomes. METHODS: This analysis derives from the European PAIN OUT infant registry providing information on perioperative pharmacological data and patient-reported outcomes 24 h after surgery. Variables associated with the endpoint 'desire for more pain treatment' were evaluated by elastic net regularisation (odds ratio [95% confidence interval]). RESULTS: Data from children undergoing appendectomy (n=472) and tonsillectomy (n=466) between 2015 and 2019 were analysed. Some 24.8% (appendectomy) and 20.2% (tonsillectomy) wished they had received more pain treatment in the 24 h after surgery. They reported higher composite pain scores (5.2 [4.8-5.5] vs 3.6 [3.5-3.8]), more pain-related interference, and more adverse events than children not desiring more pain treatment, and they received more opioids after surgery (morphine equivalents (81 [60-102] vs 50 [43-56] µg kg-1). Regression analysis revealed that pain-related sleep disturbance (appendectomy odds ratio: 2.8 [1.7-4.6], tonsillectomy 3.7 [2.1-6.5]; P<0.001) and higher pain intensities (1.5-fold increase) increased the probability of desiring more pain treatment. There was an inverse association between the number of different classes of non-opioids administered preventively, and the desire for more analgesics postoperatively. Children not receiving any non-opioid analgesics before the end of a tonsillectomy had a 3.5-fold (2.1-6.5-fold) increase in the probability of desiring more pain treatment, compared with children receiving at least two classes of different non-opioid analgesics. CONCLUSIONS: Preventive administration of at least two classes of non-opioid analgesics is a simple strategy and may improve patient-reported outcomes.

[Postoperative pain therapy after total knee arthroplasty : Is the local infiltration anesthesia the best therapy?] / Schmerz nach Knietotalendoprothese : Ist die lokale Infiltrationsanästhesie die beste Therapieoption?

BACKGROUND: Optimal perioperative pain management after total knee arthroplasty is necessary to promote mobilization and achieve early rehabilitation. The aim of this study was to determine whether local infiltration anesthesia (LIA) is the better postoperative pain therapy compared to a femoral nerve block (FNB) or a sciatic nerve block (SNB) using routine data. METHODS: Data from the acute pain registry "Qualitätsverbesserung in der postoperativen Schmerztherapie" (QUIPS) were analyzed. The endpoints included postoperative maximal pain, frequency of pain-related movement impairment, nausea, and number of patients requesting opioids postoperatively. The influence of regional anesthesia in addition to general anesthesia was analyzed in 5 groups. RESULTS: In total, the data of 8754 patients could be examined. It was found that the addition of LIA (ß = -0.087 p = 0.000) or FNB (ß = -0.137 p = 0.000) to general anesthesia is associated with a small but significant reduction of postoperative maximum pain. Between LIA, FNB, and SNB no relevant differences could be detected. DISCUSSION: The pain reduction achieved by adding LIA or FNB in patients after total knee arthroplasty is relatively small. Comparison of techniques is hindered as there exists no widely accepted standard for performing LIAs yet.

[Quality improvement in conservative pain management (QUIKS) : A module of the QUIPS project for benchmarking of pain treatment in patients with nonoperative care]. / Qualitätsverbesserung im konservativen Schmerzmanagement (QUIKS) : Ein Modul des QUIPS-Projekts zum Benchmarking der Schmerztherapie bei Patienten der nichtoperativen Versorgung.

BACKGROUND: National and international surveys have shown that the quality of pain therapy in hospitals shows deficits, especially in the nonoperative disciplines. OBJECTIVE: The objective was to develop and clinically validate a module for the outcome and process parameters for pain management in patients in the context of a conservative/nonoperative hospital treatment analogous to the QUIPS questionnaire (quality improvement in postoperative pain therapy), which focuses on postoperative pain management. MATERIAL AND METHODS: In a 4-step procedure the QUIPS outcome questionnaire and the process assessment sheet of the QUIPS module were adapted to the conditions of conservative/nonoperative treatment. Patients from internal medicine, neurology and dermatology took part in the systematic testing and the clinical validation. RESULTS: A total of 973 patients were enrolled (inclusion rate 74%, n = 403 internal medicine, n = 401 neurology, n = 169 dermatology). The majority completed the questionnaire independently while 33% of the patients needed support, which was given in the form of an interview. Apart from a few deficits, most questions about pain intensity and function were fully recorded. The evaluation of the outcome was difficult as regardless of the pain therapy, a relevant proportion of the patients reported no pain. Due to the lack of conclusive diagnoses at the time of the assessment, organ-related disease groups were developed using word diagnoses instead of the OPS coding used in QUIPS. CONCLUSION: In addition to the perioperative modules of QUIPS, QUIKS (quality improvement in conservative pain management), an instrument for quality assurance of pain treatment in patients in nonoperative disciplines, is now available.

Chronic postsurgical pain in Europe: An observational study.

BACKGROUND: Chronic postsurgical pain (CPSP) is an important clinical problem. Prospective studies of the incidence, characteristics and risk factors of CPSP are needed. OBJECTIVES: The objective of this study is to evaluate the incidence and risk factors of CPSP. DESIGN: A multicentre, prospective, observational trial. SETTING: Twenty-one hospitals in 11 European countries. PATIENTS: Three thousand one hundred and twenty patients undergoing surgery and enrolled in the European registry PAIN OUT. MAIN OUTCOME MEASURES: Pain-related outcome was evaluated on the first postoperative day (D1) using a standardised pain outcome questionnaire. Review at 6 and 12 months via e-mail or telephonic interview used the Brief Pain Inventory (BPI) and the DN4 (Douleur Neuropathique four questions). Primary endpoint was the incidence of moderate to severe CPSP (numeric rating scale, NRS ≥3/10) at 12 months. RESULTS: For 1044 and 889 patients, complete data were available at 6 and 12 months. At 12 months, the incidence of moderate to severe CPSP was 11.8% (95% CI 9.7 to 13.9) and of severe pain (NRS ≥6) 2.2% (95% CI 1.2 to 3.3). Signs of neuropathic pain were recorded in 35.4% (95% CI 23.9 to 48.3) and 57.1% (95% CI 30.7 to 83.4) of patients with moderate and severe CPSP, respectively. Functional impairment (BPI) at 6 and 12 months increased with the severity of CPSP (P < 0.01) and presence of neuropathic characteristics (P < 0.001). Multivariate analysis identified orthopaedic surgery, preoperative chronic pain and percentage of time in severe pain on D1 as risk factors. A 10% increase in percentage of time in severe pain was associated with a 30% increase of CPSP incidence at 12 months. CONCLUSION: The collection of data on CPSP was feasible within the European registry PAIN OUT. The incidence of moderate to severe CPSP at 12 months was 11.8%. Functional impairment was associated with CPSP severity and neuropathic characteristics. Risk factors for CPSP in the present study were chronic preoperative pain, orthopaedic surgery and percentage of time in severe pain on D1. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01467102.

Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial.

The purpose of this study was to describe postoperative pain within the first day after pediatric otorhinolaryngologic surgery and to identify factors influencing postoperative pain. Using a prospective evaluation and a Web-based multi-center registry, children ≥4 years of age (n = 365) rated their pain using questionnaires of the project Quality Improvement in Postoperative Pain Treatment for Children including faces numeric rating scales (FNRS, 0-10) for the determination of patient's pain on ambulation and his/her maximal and minimal pain within 8 h after day case surgery or at the first postoperative day for inpatient cases. Additionally, functional interference and therapy-related side effects were assessed. Half of the children were 4 or 5 years of age. The predominant types of surgery were adenoidectomy and tonsillectomy ± ear ventilation tubes. Although analgesics were applied preoperatively, intraoperatively, in the recovery room and on ward, maximal pain within the first day after surgery reached 4.4 ± 3.3 (FNRS). Pain was highest after oral surgery, especially after tonsillectomy and nose surgery. 39% of the children reported pain interference with breathing (39%). The most frequent side effect was drowsiness (55%). Multivariate analysis revealed that maximal pain was independently associated with the non-standardized use of opioids in the recovery room, or use of non-opioid or opioids on ward. Analgesia and perioperative pain management in pediatric otorhinolaryngologic surgery seems to be highly variable. Tonsillectomy and nose surgery are very painful. After otorhinolaryngologic surgery many children seem to receive less analgesia than needed or ineffective analgesic drug regimes.

Operation-specific risk of postoperative nausea: a cross-sectional study comparing 72 procedures.

OBJECTIVES: Determination of the procedure-specific, risk-adjusted probability of nausea. DESIGN: Cross-sectional analysis of clinical and patient-reported outcome data. We used a logistic regression model with type of operation, age, sex, preoperative opioids, antiemetic prophylaxis, regional anaesthesia, and perioperative opioids as predictors of postoperative nausea. SETTING: Data from 152 German and Austrian hospitals collected in the Quality Improvement in Postoperative Pain Treatment (QUIPS) registry from 2013 to 2022. Participants completed a validated outcome questionnaire on the first postoperative day. Operations were categorised into groups of at least 100 cases. PARTICIPANTS: We included 78 231 of the 293 947 participants from the QUIPS registry. They were 18 years or older, willing and able to participate and could be assigned to exactly one operation group. MAIN OUTCOME MEASURES: Adjusted absolute risk of nausea on the first postoperative day for 72 types of operation. RESULTS: The adjusted absolute risk of nausea ranged from 6.2% to 36.2% depending on the type of operation. The highest risks were found for laparoscopic bariatric operations (36.2%), open hysterectomy (30.4%), enterostoma relocation (29.8%), open radical prostatectomy (28.8%), laparoscopic colon resection (28.6%) and open sigmoidectomy (28%). In a logistic regression model, male sex (OR: 0.39, 95% CI 0.37 to 0.41, p<0.0001), perioperative nausea and vomiting prophylaxis (0.73, 0.7 to 0.76, p<0.0001), intraoperative regional anaesthesia (0.88, 0.83 to 0.93, p<0.0001) and preoperative opioids for chronic pain (0.74, 0.68 to 0.81, p<0.0001) reduced the risk of nausea. Perioperative opioid use increased the OR up to 2.38 (2.17 to 2.61, p<0.0001). CONCLUSIONS: The risk of postoperative nausea varies considerably between surgical procedures. Patients undergoing certain types of operation should receive special attention and targeted prevention strategies. Adding these findings to known predictive tools may raise awareness of the still unacceptably high incidence of nausea in certain patient groups. This may help to further reduce the prevalence of nausea. TRIAL REGISTRATION NUMBER: DRKS00006153; German Clinical Trials Register; https://drks.de/search/de/trial/DRKS00006153.

Pain After Outpatient Surgical Procedures.

BACKGROUND: Approximately 8.1 million outpatient surgical procedures were performed in Germany in 2021. Little is known about the quality of postoperative pain treatment in the outpatient sector. METHODS: The AQS1 project comprises a combined survey of patients and staff in the framework of quality control for ambulatory surgery. The primary endpoint of this study was the prevalence of relevant incisional pain (≥ 4/10 on the numerical rating scale) up to postoperative day 3. Secondary endpoints included prognostic variables for pain and pain-associated outcomes, based on the AQS1 patient questionnaire. Moreover, mixed regression models were used to analyze potential prognostic variables and associations of pain with other outcomes (study registration number DRKS00028052). RESULTS: Data from 330 008 patients were evaluated (from 1 July 2001 to 31 December 2021). The overall prevalence of relevant incisional pain up to postoperative day 3 was 22.5%, with major differences between different types of procedure (3.2%-51.2%). Pain was most common after hemorrhoid surgery (51.2%) and the laparoscopic lysis of large and small bowel adhesions (45.4%). The main associations of relevant pain were with younger age (odds ratio [OR] 1.87, 95% confidence interval [1.82; 1.91]), early postoperative pain (1.34, [1.30; 1.39]), inadequate provision of analgesics (2.90, [2.71; 3.09]), and surgical wound infections (2.60, [2.43; 2.78]). Patients with pain reported lower overall satisfaction with the procedure and a longer inability to work. CONCLUSION: These data have not been tested for representativeness. They can serve as a point of departure for the optimization of individualized perioperative pain therapy and for the planning of prospective studies.

Risk Factors for Severe Pain and Impairment of Daily Life Activities after Cesarean Section-A Prospective Multi-Center Study of 11,932 Patients.

Cesarean section (CS) is the most widely performed and one of the most painful surgeries. This study investigated postoperative pain after CS using patient-related outcomes (PROs) to identify risk factors for severe pain. The secondary outcome was to evaluate the influence of surgery indication (primary CS (PCS) vs. urgent CS (UCS)). This multi-center, prospective cohort study included data submitted to the pain registry "quality improvement in postoperative pain treatment" (QUIPS) between 2010 and 2020. In total, 11,932 patients were evaluated. Median of maximal pain was 7.0 (numeric rating scale (NRS) 0 to 10); 53.9% suffered from severe pain (NRS ≥ 7), this being related to impairment of mood, ambulation, deep breathing and sleep, as well as more vertigo, nausea and tiredness (p < 0.001). Distraction, relaxation, mobilization, having conversations, patient-controlled analgesia (PCA) and pain monitoring were shown to be protective for severe pain (p < 0.001). Maximal pain in PCS and UCS was similar, but UCS obtained more analgesics (p < 0.001), and experienced more impairment of ambulation (p < 0.001) and deep breathing (p < 0.05). Severe pain has a major effect on daily-life activities and recovery after CS, and depends on modifiable factors. More effort is needed to improve the quality of care after CS.

Association of Perioperative Regional Analgesia with Postoperative Patient-Reported Pain Outcomes and Opioid Requirements: Comparing 22 Different Surgical Groups in 23,911 Patients from the QUIPS Registry.

(1) Background: In many surgical procedures, regional analgesia (RA) techniques are associated with improved postoperative analgesia compared to systemic pain treatment. As continuous RA requires time and experienced staff, it would be helpful to identify settings in which continuous RA has the largest benefit. (2) Methods: On the basis of 23,911 data sets from 179 German and Austrian hospitals, we analyzed the association of perioperative RA with patient-reported pain intensity, functional impairment of movement, nausea and opioid use for different surgeries. Regression analyses adjusted for age, sex and preoperative pain were performed for each surgery and the following groups: patients receiving continuous RA (surgery and ward; RA++), RA for surgery only (RA+-) and patients receiving no RA (RA--). (3) Results: Lower pain scores in the RA++ compared to the RA-- group were observed in 13 out of 22 surgeries. There was no surgery where pain scores for RA++ were higher than for RA--. If maximal pain, function and side effects were combined, the largest benefit of continuous RA (RA++) was observed in laparoscopic colon and sigmoid surgery, ankle joint arthrodesis, revision (but not primary) surgery of hip replacement, open nephrectomy and shoulder surgery. The benefit of RA+- was lower than that of RA++. (4) Discussion: The additional benefit of RA for the mentioned surgeries is larger than in many other surgeries in clinical routine. The decision to use RA in a given surgery should be based on the expected pain intensity without RA and its additional benefits.

Desire to Receive More Pain Treatment - A Relevant Patient-Reported Outcome Measure to Assess Quality of Post-Operative Pain Management? Results From 79,996 Patients Enrolled in the Pain Registry QUIPS from 2016 to 2019.

Acute postoperative pain is frequently evaluated by pain intensity scores. However, interpretation of the results is difficult and thresholds requiring treatment are not well defined. Additional patient-reported outcome measures (PROMs) might be helpful to better understand individual pain experience and quality of pain management after surgery. We used data from the QUIPS pain registry for a cross-sectional study in order to investigate associations between the desire to receive more pain treatment (D2RMPT) with pain intensity ratings and other PROMs. Responses from 79,996 patients were analyzed, of whom 10.7% reported D2RMPT. A generalized estimating equation Poisson model showed that women had a lower risk ratio (RR) to answer this question with "yes" (RR: .92, P < .001). Factors that increased the risk most were "maximal pain intensity ≥ 6/10 on a numerical rating scale" (RR: 2.48, P < .001) and "any pain interference" (RR: 2.48, P < .001). The largest reduction in risk was observed if patients were "allowed to participate in pain treatment decisions" (RR: .41, P < .001) and if they felt that they "received sufficient treatment information" (RR: .58, P < .001). Our results indicate that the (easily assessed) question D2RMPT gives additional information to other PROMs like pain intensity. The small proportion of patients with D2RMPT (even for high pain scores) opens the discussion about clinicians' understanding of over- und under-treatment and questions the exclusive use of pain intensity as quality indicator. Future studies need to investigate whether asking about D2RMPT in clinical routine can improve postoperative pain outcome. PERSPECTIVE: This article presents characteristics of the patient-reported outcome measure "Desire to receive more pain treatment." This measure could be used to apply pain treatment in a more individualized way and lead to improved treatment strategies and quality.

Chronic Breast Pain Prior to Breast Cancer Surgery Is Associated with Worse Acute Postoperative Pain Outcomes.

Acute postoperative pain is associated with adverse short and long-term outcomes among women undergoing surgery for breast cancer. Previous studies identified preexisting pain as a predictor of postoperative pain, but rarely accounted for pain location or chronicity. This study leveraged a multinational pain registry, PAIN OUT, to: (1) characterize patient subgroups based on preexisting chronic breast pain status and (2) determine the association of preexisting chronic pain with acute postoperative pain-related patient-reported outcomes and opioid consumption following breast cancer surgery. The primary outcome was a composite score comprising the mean of pain intensity and pain interference items from the International Pain Outcomes Questionnaire. The secondary outcome was opioid consumption in the recovery room and ward. Among 1889 patients, we characterized three subgroups: no preexisting chronic pain (n = 1600); chronic preexisting pain elsewhere (n = 128) and; chronic preexisting pain in the breast with/without pain elsewhere (n = 161). Controlling for covariates, women with preexisting chronic breast pain experienced more severe acute postoperative pain and pain interference (ß = 1.0, 95% CI = 0.7-1.3, p < 0.001), and required higher doses of opioids postoperatively (ß = 2.7, 95% CI = 0.6-4.8, p = 0.013). Preexisting chronic breast pain may be an important risk factor for poor pain-related postoperative outcomes. Targeted intervention of this subgroup may improve recovery.

Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT.

OBJECTIVE: This was a pre-post study in a network of hospitals in Mexico-City, Mexico. Participants developed and implemented Quality Improvement (QI) interventions addressing perioperative pain management. METHODS: PAIN OUT, an international QI and research network, provided tools for web-based auditing and feedback of pain management and patient-reported outcomes (PROs) in the clinical routine. Ward- and patient-level factors were evaluated with multi-level models. Change in proportion of patients reporting worst pain ≥6/10 between project phases was the primary outcome. RESULTS: Participants created locally adapted resources for teaching and pain management, available to providers in the form of a website and a special issue of a national anesthesia journal. They offered teaching to anesthesiologists, surgeons, including residents, and nurses. Information was offered to patients and families. A total of 2658 patients were audited in 9 hospitals, between July 2016 and December 2018. Participants reported that the project made them aware of the importance of: training in pain management; auditing one's own patients to learn about PROs and that QI requires collaboration between multi-disciplinary teams. Participants reported being unaware that their patients experienced severe pain and lacked information about pain treatment options. Worst pain decreased significantly between the two project phases, as did PROs related to pain interfering with movement, taking a deep breath/coughing or sleep. The opportunity of patients receiving information about their pain treatment options increased from 44% to 77%. CONCLUSIONS: Patients benefited from improved care and pain-related PROs. Clinicians appreciated gaining increased expertise in perioperative pain management and methods of QI.

Non-Pharmacological Methods and Post-Operative Pain Relief: An Observational Study.

BACKGROUND: Non-pharmacological methods (NPMs) like cold packs, acupuncture, meditation or distractions are supposed to ease acute post-surgical pain. OBJECTIVES: This study assessed how frequently these methods are used in clinical routine and if their use is associated with pain relief or with the wish for more pain treatment. METHODS: Data from the world's largest acute post-operative pain registry, PAIN OUT, was used for this study. In PAIN OUT, patients report their pain levels and side effects related to pain therapy after surgery. Overall, 15 different NPMs were tested for their association with pain relief and the wish for more pain treatment using Mann-Whitney U test, Kruskal-Wallis test, General Linear Model, and Logistic Regression. The researchers adjusted for age and gender, and specifically looked at the three most frequent surgeries: total knee replacement, total hip replacement, and laparoscopic cholecystectomy. RESULTS: Data of 14 767 patients from 12 European hospitals were analyzed. Overall, 6563 (44.4%) patients used at least one NPM; with distraction and cold packs being the most frequently used. The 8204 (55.6%) patients, who did not use NPMs had little yet significantly more pain relief than patients, who used them (means of 71.2% ± 27.9% versus 68.6% ± 25.7%, P < 0.001). Using NPMs does not affect the wish for more pain treatment. This is true for every single NPM. The only exceptional sub-group included total knee replacement patients, where a positive effect of NPMs was observed. CONCLUSIONS: Some NPMs are widely used while others are rarely applied. Their association with pain relief is doubtful. These findings add to a rather contradictory literature. Advantages and disadvantages of applying NPMs solely for pain relief should thus be considered carefully.

The Quality of Postoperative Pain Therapy in German Hospitals.

BACKGROUND: Many patients in German hospitals complain of inadequate treatment of their postoperative pain. Hospital-related structural and procedural variables may affect pain perception and patient satisfaction. We studied the association of individual variables with outcome quality. METHODS: Data from the years 2011 to 2014 from the world's largest acute pain registry (QUIPS) were evaluated. The analysis was performed with mixed linear regression models. RESULTS: We studied registry data from 138 German hospitals concerning four commonly performed types of operations (total number of operations, 21 114) and found that the intensity of pain, functional impairment, and satisfaction with postoperative pain therapy were all highly variable from one hospital to another. Patients in university hospitals complained more often than those in standard care facilities of highly intense pain (odds ratio [OR] 2.44; 95% con - fidence interval [CI] [1.18; 5.04]) and dissatisfaction (OR 3.58 [1.85; 6.93]). In specialized centers as well, pain intensity (OR 1.39 [1.06; 1.83]) and dissatisfaction (OR 1.59 [1.25; 2.02]) were higher. Pain-related limitation of movement was also reported more commonly in university hospitals (OR 2.12 [0.87; 5.16]) and specialized centers (OR 1.87 [1.33; 2.65]) than in standard care facilities. Less pain-related limitation of movement and higher satisfaction were reported in hospitals in which pain was documented in the patients' charts and the patients felt adequately informed about the treatment options. CONCLUSION: The current state of postoperative pain therapy leaves much room for improvement. Quality indicators in the field of acute pain medicine might help improve patient care.

Inter-Hospital Variability of Postoperative Pain after Tonsillectomy: Prospective Registry-Based Multicentre Cohort Study.

OBJECTIVES: Although tonsillectomy is one of the most frequent and painful surgeries, the association between baseline and process parameters and postoperative pain are not fully understood. METHODS: A multicentre prospective cohort study using a web-based registry enrolled 1,527 women and 1,008 men aged 4 to 85 years from 52 German hospitals between 2006 and 2015. Maximal pain (MP) score the first day after surgery on a numeric rating scale (NRS) from 0 (no pain) to 10 (MP) was the main outcome parameter. RESULTS: The mean maximal pain score was 5.8±2.2 (median 6). Multivariable analysis revealed that female gender (Odds ratio [OR] = 1.33; 95% confidence interval [CI] = 1.12 to 1.56; p = 0.001), age <20 years (OR = 1.56; CI = 1.27 to 1.91; p<0.0001), no pain counselling (OR = 1.78; CI = 1.370 to 2.316; p<0.001), chronic pain (OR = 1.34; CI = 1.107 to 1.64; p = 0.004), and receiving opioids in recovery room (OR = 1.89; CI = 1.55 to 2.325; p<0.001) or on ward (OR = 1.79; CI = 1.42 to 2.27; p<0.001) were independently associated with higher experienced maximal postoperative pain (greater the median of 6). The effect of age on pain was not linear. Maximal pain increased in underage patients to a peak at the age of 18 to 20 years. From the age of ≥20 years on, maximal pain after tonsillectomy continuously decreased. Even after adjustment to all statistically important baseline and process parameters, there was substantial variability of maximal pain between hospitals with a heterogeneity variance of 0.31. CONCLUSION: Many patients seem to receive insufficient or ineffective analgesia after tonsillectomy. Further research should address if populations at risk of higher postoperative pain such as females, younger patients or those with preexisting pain might profit from a special pain management protocol. Beyond classical demographical and process parameters the large variability between different hospitals is striking and indicates the existence of other unknown factors influencing postoperative pain after tonsillectomy.

Howling at the moon? The effect of lunar phases on post-surgical pain outcome.

OBJECTIVE: Many people are convinced that lunar phases influence their lives - despite the fact that a lot of studies have shown that this belief is wrong. In this article, we investigate the effect of lunar phases on acute post-surgical pain and on treatment-related side effects. We hypothesize that there is no influence. METHODS: The data for the study were collected in 2010 and 2011 in 10 international hospitals participating in the research project PAIN OUT. Hospitalized patients were asked for their pain after surgery and pain treatment side effects using numerical ratings scales from 0 to 10. We applied Kurskal-Wallis H-tests to find out if the four moon phases show significant differences in 14 outcome variables. Afterwards, we adjusted for age, gender and three tracer surgeries. RESULTS: A total of 12,224 patient data sets were assessed. For most variables and sub-groups, there is no lunar effect on the observed outcome variables. The only items that show statistically significant differences are pain interference with sleep (p = 0.01) and drowsiness (p = 0.01). The only sub-groups that show statistically significant connections to lunar phases in some variables are men (7 out of 14 variables significant) and elderly people (4 out of 14 variables significant). DISCUSSION: Even in the statistically significant sub-groups, the differences are small and only show up in some variables. We conclude that lunar phases have no effect on post-surgical pain or its side effects. The hypothesis holds. Thus, there is no reason for patients to postpone surgeries or to fear surgeries on any given date.