Perioperative celecoxib administration for pain management after total knee arthroplasty – A randomized, controlled study

<p>Abstract</p> <p>Background</p> <p>Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for multimodal postoperative pain management. We evaluated opioid-sparing effects and rehabilitative results after perioperative celecoxib administration for total knee arthroplasty.</p> <p>Methods</p> <p>This was a prospective, randomized, observer-blind control study. Eighty patients that underwent total knee arthroplasty were randomized into two groups of 40 each. The study group received a single 400 mg dose of celecoxib, one hour before surgery, and 200 mg of celecoxib every 12 hours for five days, along with patient-controlled analgesic (PCA) morphine. The control group received only PCA morphine for postoperative pain management. Visual analog scale (VAS) pain scores, active range of motion (ROM), total opioid use and postoperative nausea/vomiting were analyzed.</p> <p>Results</p> <p>Groups were comparable for age, pre-operative ROM, operation duration and intraoperative blood loss. Resting VAS pain scores improved significantly in the celecoxib group, compared with controls, at 48 hrs (2.13 ± 1.68 vs. 3.43 ± 1.50, p = 0.03) and 72 hrs (1.78 ± 1.66 vs. 3.17 ± 2.01, p = 0.02) after surgery. Active ROM also increased significantly in the patients that received celecoxib, especially in the first 72 hrs [40.8° ± 17.3° vs. 25.8° ± 11.5°, p = 0.01 (day 1); 60.7° ± 18.1° vs. 45.0° ± 17.3°, p = 0.004 (day 2); 77.7° ± 15.1° vs. 64.3° ± 16.9°, p = 0.004 (day 3)]. Opioid requirements decreased about 40% (p = 0.03) in the celecoxib group. Although patients suffering from post-operative nausea/vomiting decreased from 43% in control group to 28% in celecoxib group, this was not significant (p = 0.57). There were no differences in blood loss (intra- and postoperative) between the groups. Celecoxib resulted in no significant increase in the need for blood transfusions.</p> <p>Conclusion</p> <p>Perioperative celecoxib significantly improved postoperative resting pain scores at 48 and 72 hrs, opioid consumption, and active ROM in the first three days after total knee arthroplasty, without increasing the risks of bleeding.</p> <p>Trial registration</p> <p>Clinicaltrials.gov NCT00598234</p

The PINE study: rationale and design of a randomised comparison of epidural injection of local anaesthetics and steroids versus care-as-usual to prevent postherpetic neuralgia in the elderly [ISRCTN32866390]

BACKGROUND: Postherpetic neuralgia (PHN) is by far the most common complication of herpes zoster (HZ) and one of the most intractable pain disorders. Since PHN is seen most often in the elderly, the number of patients with this disorder is expected to increase in our ageing society. PHN may last for months to years and has a high impact on the quality of life. The results of PHN treatment are rather disappointing. Epidural injection of local anaesthetics and steroids in the acute phase of HZ is a promising therapy for the prevention of PHN. Since randomised trials on the effectiveness of this intervention are lacking, the PINE (Prevention by epidural Injection of postherpetic Neuralgia in the Elderly) study was set up. The PINE study compares the effectiveness and cost-effectiveness of a single epidural injection of local anaesthetics and steroids during the acute phase of HZ with that of care-as-usual (i.e. antivirals and analgesics) in preventing PHN in elderly patients. METHODS / DESIGN: The PINE study is an open, multicenter clinical trial in which 550 elderly (age ≥ 50 yr.) patients who consult their general practitioner in the acute phase of HZ (rash < 7 days) are randomised to one of the treatment groups. The primary clinical endpoint is the presence of HZ-related pain one month after the onset of the rash. Secondary endpoints include duration and severity of pain, re-interventions aiming to treat the existing pain, side effects, quality of life, and cost-effectiveness. CONCLUSION: The PINE study is aimed to quantify the (cost-) effectiveness of a single epidural injection during the acute phase of HZ on the prevention of PHN

Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting.</p> <p>Methods and design</p> <p>An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up.</p> <p>Discussion</p> <p>This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS.</p> <p>Trial registration</p> <p>Trial registration number: <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2575">NTR2575</a></p

Correlational analysis and predictive validity of psychological constructs related with pain in fibromyalgia

<p>Abstract</p> <p>Background</p> <p>Fibromyalgia (FM) is a prevalent and disabling disorder characterized by a history of widespread pain for at least three months. Pain is considered a complex experience in which affective and cognitive aspects are crucial for prognosis. The aim of this study is to assess the importance of pain-related psychological constructs on function and pain in patients with FM.</p> <p>Methods</p> <p>Design</p> <p>Multicentric, naturalistic, one-year follow-up study.</p> <p><it>Setting and study sample</it>. Patients will be recruited from primary care health centres in the region of Aragon, Spain. Patients considered for inclusion are those aged 18-65 years, able to understand Spanish, who fulfil criteria for primary FM according to the American College of Rheumatology, with no previous psychological treatment.</p> <p>Measurements</p> <p>The variables measured will be the following: main variables (pain assessed with a visual analogue scale and with sphygmomanometer and general function assessed with Fibromyalgia Impact Questionnaire, and), psychological constructs (pain catastrophizing, pain acceptance, mental defeat, psychological inflexibility, perceived injustice, mindfulness, and positive and negative affect), and secondary variables (sociodemographic variables, anxiety and depression assessed with Hospital Anxiety and Depression Scale, and psychiatric interview assessed with MINI). Assessments will be carried at baseline and at one-year follow-up.</p> <p>Main outcome</p> <p>Pain Visual Analogue Scale.</p> <p>Analysis</p> <p>The existence of differences in socio-demographic, main outcome and other variables regarding pain-related psychological constructs will be analysed using Chi Square test for qualitative variables, or Student <it>t </it>test or variance analysis, respectively, for variables fulfilling the normality hypothesis. To assess the predictive value of pain-related psychological construct on main outcome variables at one-year follow-up, use will be made of a logistic regression analysis adjusted for socio-demographic and clinical variables. A Spearman Rho non-parametric correlation matrix will be developed to determine possible overlapping between pain-related psychological constructs.</p> <p>Discussion</p> <p>In recent years, the relevance of cognitive and affective aspects for the treatment of chronic pain, not only in FM but also in other chronic pain diseases, has been widely acknowledged. However, the relative importance of these psychological constructs, the relationship and possible overlapping between them, or the exact meaning of them in pain are not enough known.</p