Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
Study NCT ID:
NCT04448457
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
Sponsor:
Centre Hospitalier Universitaire de Tivoli
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: