Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
Study NCT ID:
NCT03373851
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2017-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain
Status:
COMPLETED
Status Verified Date:
2022-09
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:
USE-SSPC
Brief Summary:
Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.
Detailed Description:
None
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?: