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

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.

Sufentanil sublingual tablet system for enhanced recovery after total knee arthroplasty: a prospective observational case study

“…Pain appeared however to be effectively controlled in both groups, confirming the efficacy of SSTS for the control of postoperative pain after knee arthroplasty (Jove et al 2015 ; Meijer et al 2018 ; Melson et al 2014 ; Scardino et al 2018 ). But, although its use has been shown to be effective in treating postoperative pain in various surgeries, including major orthopedic surgery, no clinically significant difference has been observed in comparison with other usual effective analgesic techniques such as the PCA morphine so far (Noel et al 2020 ; van Veen et al 2018 ).…”

Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study

“…SSTS and oral oxycodone have approximately the same onset (15–30 min) [18, 21] but SSTS does not expose patients to prolonged analgesic gaps due to absence of involvement of nurses in analgesic administration. Lack of gap and better titration should optimize pain control as seen with other PCA systems as suggested previously [23]. This optimized analgesia was not reflected in our study neither in a retrospective trial on 227 patients operated for TKA in an ERAS environment [29].…”

“…The efficacy on postoperative pain relief has been shown in randomized controlled trials (RCT) for abdominal surgeries [16,18,21], plastic surgery [12] and major orthopedic surgeries [8,16]. However, to our knowledge, use of SSTS in ERAS protocols has been reported only in few observational studies which conclude on the efficacy and the safety of the technique [23,26,29]. RCT comparing SSTS to an oral opioid effective regimen are also lacking.…”

Sufentanil sublingual tablet system (Zalviso®) as an effective analgesic option after thoracic surgery: An observational study

“…Analgesia with SSTS has been demonstrated to be an effective strategy for pain control after major abdominal and orthopedic surgery. [9101112]…”