NCT04448457

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

Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Centre Hospitalier Universitaire de Tivoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context. After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil Sublingual Tablet	15 mcg with lockout interval of 20 min
DRUG	Oxycodone oral tablet and oxycodone extended-release oral tablet	Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2020-06-25
• Last updated: 2020-06-25

Locations

1 site across 1 country: Belgium