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

Marco Scardino,Dario Bugada,Vincenzo Simili,Tiziana D’Amato,Berardo Di Matteo,Elizaveta Kon,Federica Martorelli,Giorgia Fenocchio

doi:10.1186/s40634-018-0123-y

Abstract

BackgroundCurrently 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.MethodsThe 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.ResultsNRS 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.ConclusionOur 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.

Highlights

Many total knee arthroplasty (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
The study evaluated a total of 95 patients using the sublingual sufentanil patient-controlled analgesia (PCA) system (SSTS) drug/device Zalvisio® (SSTS group) and compared it to a control group of 87 patients on continuous femoral nerve block which was representative of the typical TKA hospital population, presenting similar characteristics as to age, comorbidities, type of operation with the SSTS group, differing limitedly to the analgesic technique received (Table 1)
The present study evaluated the efficacy and safety of Zalviso® sublingual sufentanil tablet system (SSTS) in comparison to our standard of care for postoperative pain management, a multimodal analgesic approach with continuous femoral nerve block (cFNB), in a population of TKA patients managed according to fast track rehabilitation principles

Summary

Introduction

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. Used anaesthetic/analgesic strategies that are known to perform best in orthopaedic surgery may not, meet performance requirements for the fast track recovery (Sacerdote et al, 2016; Rawal, 2016). This is true for continuous femoral nerve block (cFNB), which has been acknowledged as the most effective in TKA (Chan et al, 2014; Ilfeld, 2017; Albrecht et al, 2016). Traditional opioid patient-controlled analgesia (PCA), which are extensively used concomitantly with peripheral nerve blocks and local anesthetics, are less suitable in the setting of fast track recovery. In the case of local infiltration anaesthesia (LIA) –despite it being effective in controlling pain on the day of surgery– it is not effective in management of movement-evoked pain in the days following surgery

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