Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

Summary

The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehabilitation program. SSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization. SSTS will be randomly compared to nurse-driven oral Oxycodone.

Timeline

Start

2017-09-01

Primary completion

2018-07-31

Completion

2018-07-31

Outcome

Missed primary endpoint

paper 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) PMID 33216238 ↗

paper 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. PMID 33216238 ↗

Publications

• Noel E, Miglionico L, Leclercq M, Jennart H, Fils JF, Van Rompaey N. 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. J Exp Orthop. 2020 Nov 20;7(1):92. doi: 10.1186/s40634-020-00306-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	5 mg	Oral
Comparator	Oxycodone	Other / unclassified	10 mg	Oral
Subject	Sufentanil	Other / unclassified	15 ug	Other

Indications

No indication recorded.