Ricerc@Sapienza

Background and Aims: Inadequate post-operative pain management is one
of the most common complain after major orthopedic surgery. Limits of iv-
PCA have been identified in programming and patients' errors, invasive access,
and impairment of mobility. The aim of this study was to evaluate patient' perspective
into sufentanil sublingual tablet system Zalviso®(SSTS) evaluation for
post-operative pain management after orthopedic surgery.
Methods: Adults, who had undergone major orthopedic surgery, with expected
postoperative pain ≥4 on a 11-point numeric rating scale, received SSTS 15mcg,
with a 20-minute lockout interval, as requested for pain, over the 72-hour study
period. Datawere collected at baseline (T0) and 3, 6, 12, 24, 36, 48, 60, 72 hours
after surgery. The primary endpoint was the Patient Global Assessment (PGA)
on a 5-point categorical scale. Secondary endpointswere analgesic efficacy, need
for supplemental rescue doses, and sleep pain interference.
Results: 36 patientswere enrolled. 97.2%of patients evaluated the treatment as
excellent or very good on PGA. No patients discontinued due to inadequate analgesia
or adverse events. Required SSTS doses ranged from 5 to 48 in 72 hours.
SSTS doses were significantly higher in TKA (29.8), compared with THA (22).
Mean required SSTS doses in different surgeries are shown in Figure 1. Rescue
doses were needed in 5.5% of SSTS patients. Quality of sleep was good or
very good in 86.1% of patients on the same day of surgery.
Conclusions: SSTS was well accepted by patients undergoing major orthopedic
surgery and resulted in effective management of moderate-to-severe acute
postoperative pain.