Sublingual sufentanil tablet system for the management of acute postoperative pain in a hospital setting: an observational study.

BACKGROUND: The use of a strong opioid with intravenous patient-controlled analgesia (IV-PCA) is recommended for postoperative pain, but its use is restricted due to technical problems. Other delivery systems, like sublingual PCA, with the sufentanil tablet system (SSTS) device, could overcome the safety concerns related to IV-PCA. METHODS: This prospective observational study evaluated the efficacy, safety and usability of SSTS for post-surgical analgesia in the real-life setting. RESULTS: Two-hundred-ninety-eight subjects (125 males), ranging 18-87 years who were undergoing a surgical intervention with a necessity for postoperative analgesia in a hospital setting, were analyzed for SSTS efficacy and safety. The primary end point (success of treatment according to Patient Global Assessment of the Method of Pain Control [PGA] on the second postoperative day) was achieved in 89.8% (95% CI: 85.6-93.1%, P≤0.001 from a presumed value of 60%). During the first 24 hours, pain was below the baseline score (1.2±1.4 after four hours and 1.8±1.6 after 20 hours). The mean impairment in quality of sleep was 1.7±1.7 on postoperative day 1. The overall nurse ease of care (EOC) and nurses' satisfaction questionnaire score was 4.6±0.6, and 4.1±0.9, respectively. The overall patient EOC score was 4.3±0.5; 93.5% patients were extremely satisfied/satisfied with pain control and 93.2% were extremely satisfied/satisfied with the way of the administration. CONCLUSIONS: Under a real-life clinical practice setting, SSTS provides effective pain management and is easy to use for patients and nurses.

Tapentadol vs oxycodone/naloxone in the management of pain after total hip arthroplasty in the fast track setting: an observational study.

BACKGROUND: In recent years, joint replacement surgery has gradually progressed towards the fast-track model, and early rehabilitation immediately after surgery is regarded fundamental for optimal recovery of function: the aim of the present study is to describe the efficacy in perioperative management of pain in patients undergoing total hip replacement surgery and treated with tapentadol or oxycodone/naloxone in combination with ketoprofene. METHODS: Single-center retrospective study on patients with moderate-severe pain, referred to total hip replacement. Patients received either tapentadol (100 mg/twice-daily post-surgery - treatment group) or oxycodone/naloxone (10 mg/5 mg post-surgery - control group) plus ketoprofen 100 mg/ twice daily. Supplemental analgesia (paracetamol 1 g or morphine 0,1 mg/kg sc) was provided if needed. Pain at rest and pain during movement were evaluated on a daily basis for 4 days post-op, after which patients were usually discharged. All adverse events were reported and compared between the two groups. RESULTS: 106 patients were analyzed in the tapentadol group and compared to 105 patients treated with oxycodone/naloxone. Both pain intensity at rest and upon movement were significantly lower in the tapentadol group at all follow-up times (p < 0.001). Throughout T1-T4, supplemental analgesia was needed by significantly less tapentadol patients compared to the control group. Similarly, regarding side effects, a significantly higher occurrence of post-op nausea, vomit, itching and constipation was observed in the control group (p < 0.001 in all cases). CONCLUSION: Results from the present study support the use of tapentadol in combination with ketoprofen for the management of moderate-severe pain in the setting of major orthopedic surgery, given its effectiveness in reducing pain intensity, and its satisfactory tolerance.

Use of a fibrin sealant within a blood-saving protocol in patients undergoing revision hip arthroplasty: effects on post-operative blood transfusion and healthcare-related cost analysis.

PURPOSE: Blood transfusion and blood management are important aspects in orthopaedic surgery. Strategies include intra-operative and post-operative blood salvage and even the use of fibrin sealant in selected case. Objectives of the study were (1) to compare the total number of transfusions and the length of hospital stay in patients undergoing complete revision hip arthroplasty (RHA) with and without the use of a fibrin sealant (EVICEL®) and (2) to evaluate the possible role in cost savings of EVICEL® in association with the blood-saving protocol. METHODS: Retrospective observational study evaluating patients undergoing complete RHA (stem + cup) with a blood-saving protocol with (n = 50) and without EVICEL® (n = 60). The outcome measures were: number of patients transfused (allogeneic red blood cells-RBC-and plasma), amount of blood/plasma transfusions, quantity of re-infused recycled blood, and length of hospital stay. An economic model was developed to assess the differences in costs between the two groups. RESULTS: EVICEL® reduced the number of transfused red blood cells and plasma (p < 0.001), and the hospital stay (p = 0.01) compared to control group. EVICEL® can induce a reduction in resource consumption with an average cost-savings of €1.676 per patient. CONCLUSION: EVICEL® may be effective in reducing red blood cells and plasma transfusion as well as hospital stay. The inclusion of EVICEL® in a blood-saving protocol seems to produce clinical efficacy and cost savings.

Improved patient blood management and cost saving in hip replacement surgery through the implementation of pre-operative Sucrosomial® iron supplementation: a quality improvement assessment study.

PURPOSE: To compare post-operative recovery of prosthetic hip surgery patients with or without the implementation of iron supplementation with a new highly absorbable oral iron formulation. METHODS: Observational retrospective quality improvement assessment conducted on patients who had undergone elective prosthetic hip surgery (first implant) with ferritin < 100 mcg/dl and Hb values between 13 and 14 g/dl for men and 12 g/dl and 13.5 g/dl for women, or having ferritin levels > 100 mcg/dl but C-reactive protein (CRP) > 3 mg/l and transferrin saturation (TSAT) < 20%, which together are suggestive of functional iron deficiency. The analysis compared a group of non-anaemic patients having ferritin levels > 100 mcg/l to two groups of patients with iron deficiency, of which only one received iron supplementation. Measurements included haemoglobin levels, length of hospital stay, and number of transfused patients/blood units. RESULTS: Patients with iron deficiency supplemented with Sideral® Forte compared to non-supplemented patients showed a smaller decline in post-operative Hb (9.7 ± 1.24 g/dl vs 8.4 ± 0.6 g/dl), required shorter hospital stay (4 vs 6.5 days) and less blood transfusions (0 in the iron-supplemented group vs 7 units in the non-iron-supplemented group), yielding an overall savings of 1763.25 €/patient. CONCLUSIONS: Pre-operative sucrosomial iron supplementation at least 4 weeks prior to elective surgery in non-anaemic patients limits the drop in post-operative Hb levels, determining higher post-operative haemoglobin, quicker post-surgical recovery, shorter hospitalisation, and decreased surgery-related costs.

Sublingual sufentanil tablet system Zalviso® for postoperative analgesia after knee replacement in fast track surgery: a pilot observational study.

BACKGROUND: Currently many TKA protocols rely on multimodal analgesic protocols with patient-controlled analgesia systems that administer opioids through a patient controlled IV infusion pump, in addition to concomitant peripheral nerve blocks and local anesthetics. Although effective, PCA IV opioids do not provide optimal results with fast track rehabilitation protocols. METHODS: The present is a retrospective study comparing the novel sublingual sufentanil PCA system (SSTS) to our standard of care foreseeing continuous femoral nerve block (cFNB) within a multimodal analgesic in a TKA fast-track protocol. The study evaluated 95 patients on SSTS (SSTS group) and 87 on cFNB (cFNB/control group) and collected data on numeric rating scores for pain from day 1-3 after surgery (T1, T2, T3), both at rest (NRS) and during movement (mNRS), patient's ability to walk, need for supplementary analgesia (rescue dose), occurrence of adverse effects, length of hospital stay, and usability rating for SSTS by both patients and hospital staff. RESULTS: NRS at rest was lower in the cFNB than in the SSTS group for all 3 days after surgery, whereas mNRS scores were lower in the SSTS group at all time points measured. Adverse effects were significantly fewer among patients of the SSTS group (6% patients) than those of the cFNB (74% patients) (p <  0.001). Rescue doses were needed by 5% of SSTS patients vs 60% of cFNB. The fewer adverse events and lower pain scores for the SSTS group were associated to a notably better ability to ambulate, with all patients (100%) of the SSTS group being able to stand and walk for 10 m from T1 on; patients in the cFNB group showed a slower recovery with only 40% being able to stand and walk on T1, 70% on T2 and 85% on T3. All patients of the SSTS group had a length of stay of 4 days (day of surgery plus 3 after) as foreseen by the fast track protocol, in comparison only 36% of cFNB. Lastly, patient and nursing staff judged SSTS easy to use. CONCLUSION: Our experience suggests that SSTS is a valuable strategy for routine postoperative analgesia following TKA in the context of a multimodal analgesic approach within the fast-track setting.

Activity-based costing analysis of the analgesic treatments used in postoperative pain management in Italy.

BACKGROUND: The aim of this analysis is to evaluate the costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in nine different Italian hospitals, defined as the cumulative cost of drugs, consumable materials and time required for anesthesiologists, surgeons and nurses to administer each analgesic technique. METHODS: Nine Italian hospitals have been involved in this study through the administration of a questionnaire aimed to acquire information about the Italian clinical practice in terms of analgesia. This study uses activity-based costing (ABC) analysis to identify, measure and give value to the resources required to provide the therapeutic treatment used in Italy to manage the postoperative pain patients face after surgery. A deterministic sensitivity analysis (DSA) has been performed to identify the cost determinants mainly affecting the final cost of each treatment analyzed. Costs have been reclassified according to three surgical macro-areas (abdominal, orthopedic and thoracic) with the aim to recognize the cost associated not only to the analgesic technique adopted but also to the type of surgery the patient faced before undergoing the analgesic pathway. RESULTS: Fifteen different analgesic techniques have been identified for the treatment of moderate to severe pain in patients who underwent a major abdominal, orthopedic or thoracic surgery. The cheapest treatment actually employed is the oral administration "around the clock" (€ 8.23), whilst the most expensive is continuous peripheral nerve block (€ 223.46). The intravenous patient-controlled analgesia costs € 277.63. In terms of resources absorbed, the non-continuous administration via bolus is the gold standard in terms of cost-related to the drugs used (€ 1.28), and when administered pro re nata it also absorbs the lowest amount of consumables (€0.58€) compared to all other therapies requiring a delivery device. The oral analgesic administration pro re nata is associated to the lowest cost in terms of health professionals involved (€ 6.25), whilst intravenous PCA is the most expensive one (€ 245.66), requiring a massive monitoring on the part of physicians and nurses. CONCLUSIONS: The analysis successfully collected information about costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in all the nine different Italian hospitals. The interview showed high heterogeneity in the treatment of moderate to severe pain after major abdominal, orthopedic and thoracic surgeries among responding anesthesiologists, with 15 different analgesic modalities reported. The majority of the analgesic techniques considered in the analysis is not recommended by any guideline and their application in real life can be one of the reasons for the high incidence of uncontrolled pain, which is still reported in the postoperative period. Health care costs have become more and more important, although the choice of the best analgesic treatment should be a compromise between efficacy and economic considerations.