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

Emmanuel Noel, Luca Miglionico, Mickael Leclercq, Harold Jennart, Jean-François Fils, Nicolas Van Rompaey, Emmanuel Noel, Luca Miglionico, Mickael Leclercq, Harold Jennart, Jean-François Fils, Nicolas Van Rompaey

Abstract

Purpose: Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol.

Methods: This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10 mg twice daily and oral oxycodone immediate-release 5 mg up to four times daily on demand (Oxy group) to control pain during 48 h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24 h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded.

Results: Median pain score at 24 h at rest was 3 [2-4] for Oxy group vs 2 [1.75-3] for SSTS group (p = 0.272) whereas median pain score on movement was 4 [3-6] vs 3 [2-5] respectively (p = 0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p = 0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181).

Conclusions: In complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty.

Trial registration: Clinical Trials: NCT04448457 ; retrospectively registered on June 24, 2020. https://ichgcp.net/clinical-trials-registry/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3.

Keywords: Fast track; Knee arthroplasty; Multimodal analgesia; Opioids; Oxycodone; Postoperative pain; Sufentanil.

Conflict of interest statement

The authors have no disclosure for this research.

Grünenthal GmbH provided our hospital with non-financial support. Specifically, this company offered a free rental of the zalviso administration device (sufentanil cartridge not included) without any compensation.

Figures

Fig. 1
Fig. 1
Participant Flow (CONSORT diagram). SSTS = sufentanil sublingual tablet system
Fig. 2
Fig. 2
Box and whisker plots of postoperative pain score at 24 h a. Pain score at rest. b. Dynamic pain score. Solid horizontal lines represent the median, boxes indicate interquartile range (Q25-Q75), whiskers represent 5th percentile and 95th percentile and dots are the extreme values. No statistical difference was found
Fig. 3
Fig. 3
Box and whisker plots of postoperative pain scores over 48 h. a. Pain score at rest. b. Dynamic pain score. Solid horizontal lines represent the median, boxes indicate interquartile range (Q25-Q75), whiskers represent 5th percentile and 95th percentile and dots are the extreme values. No statistical difference was found. SSTS = sufentanil sublingual tablet system
Fig. 4
Fig. 4
Kaplan–Meier cumulative event rates for time to first mobilization. Solid square indicates censored patient. No statistical difference was found. SSTS = sufentanil sublingual tablet system
Fig. 5
Fig. 5
Patient Satisfaction

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