Background and Goal of Study:
The sufentanil sublingual tablet system (SSTS; Zalviso®) is a novel patient-controlled analgesia (PCA) device intended to overcome some of the drawbacks of opioid-based intravenous PCA. Based on the results of three phase III studies, the SSTS has been approved in the EU for the management of acute moderate to severe postoperative pain in adults in a hospital setting. This case series presents the experience with the SSTS after orthopedic surgery in 50 patients, from May to October 2017, 23 after total knee arthroplasty (TKA), 10 total hip arthroplasty (THA) and 17 anterior cruciate ligament reconstructions (ACLR).
Materials and Methods:
All patients received a spinal anesthesia with bupivacaine 10-12.5mg for knee surgery and levobupivacaine 10-12.5mg for hip surgery. After surgery, the first dose of sublingual sufentanil was administered before reversion of the sensory block. Patients also received a combination of paracetamol plus non-steroidal antiinflammatory drug (NSAID). The SSTS was maintained up to 72h and adverse events were recorded. Data were downloaded from the devices and patients were contacted 1 to 3 months after discharge, to evaluate the degree of satisfaction with the SSTS, in a 0 to 5 scale (0 – totally unsatisfied; 1 – very unsatisfied; 2 – unsatisfied; 3 – satisfied; 4 – very satisfied; 5 – totally satisfied).
Results and Discussion:
The incidence of adverse events was 6% for pruritus, 6% for dizziness, 2% for nausea without vomiting and 2% for nausea with vomiting. The cumulative incidence was 8%. All events were mild to moderate and controlled with rescue therapy. No other adverse events were recorded. The average patient global satisfaction was 4,3, ranging from 2 to 5. The average treatment duration was 48,4 hours [Standard Deviation (SD) 20,7], with a average consumption of 17,7 tablets (SD 10,8). The average interval between tablets was 204,8 minutes, with a average interval of 126,4 minutes on the first day, 290,9 minutes on the second day and 391,6 minutes on the third day. Data also showed a higher consumption in younger patients, with a higher incidence of nausea and vomiting in this subgroup. The other adverse events had no relevant tendency.
Conclusions:
The sufentanil sublingual tablet system is a valid alternative for postoperative pain control in major orthopedic surgery, with a high patient global satisfaction and low incidence of adverse events.

06 / Sublingual sufentanil patient-controlled analgesia in orthopedic surgery: a case series