Safety and efficacy of patient controlled analgesia using the Sublingual Sufentanil Tablet System (SSTS) in a fast track rehabilitation program after Total Knee arthroplasty
knee arthroplasty, sublingual sufentanil tablet system (SSTS), postoperative pain
Published online: May 16 2024
Abstract
Background: Postoperative pain can delay recovery after total knee arthroplasty (TKA). Currently, many postoperative TKA protocols rely primarily on multimodal analgesic tools with patient-controlled intravenous analgesia (PCIA) systems or nurse-controlled oral opioid tablets. However, both systems have disadvantages as to patient autonomy and mobility and may even create analgesic gaps. The sublingual Sufentanil tablet system (SSTS, Zalviso®, Grünenthal, Germany) could be beneficial in a fast track rehabilitation program, after total knee arthroplasty (TKA). SSTS is non-invasive and imposes no restrictions on patient mobility and improves patient autonomy.
Objective: The aim of this study was to investigate if SSTS provides effective and safe postoperative analgesia that allows early mobilization after TKA.
Design: Prospective cohort study
Methods: Sixty eight patients underwent TKA under spinal and locoregional anaesthesia. Postoperative analgesia consisted of IV paracetamol, oral NSAID’s, supplemented with SSTS. The primary outcome was the absence of therapeutic failure, defined as the occurrence of consecutive NRS scores ≥4 despite optimal use of the SSTS. Discontinuation of study medication due to severe adverse events was also considered as therapeutic failure. Patient, Nurse and Physiotherapist- Ease- Of Care questionnaires were completed at the end of the study.
RESULTS: Therapeutic success was achieved in 68% of the cases with a 95% Wilson Confidence Interval (56.3%-77.9%). No serious adverse events were reported. The Length of Hospital Stay was 2 days for all patients. The incidence of PONV was high: nausea in 19%, 26% and 10% on day 0,1 and 2 respectively; vomiting in 7%, 10% and 1% on day 0,1 and 2 respectively.
Conclusions: The success rate of SSTS is similar to the reported success rates for parenteral PCA devices and oral opioids, providing adequate analgesia at rest and during mobilization after TKA. The system is safe and user friendly both for patients and health workers. The incidence of nausea and vomiting is high and needs to be anticipated. and oral opioids. A high incidence of nausea and vomiting is reported with the use of Zalviso.
Trial registration: The trial was registered at ClinicalTrials.gov (NCT04432428).
