Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-31 @ 4:23 PM
Study NCT ID:
NCT04432428
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2020-01
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:
Zalviso
Brief Summary:
The sufentanil sublingual tablet system (SSTS) is an innovative patient-controlled analgesia (PCA) device for the management of acute moderate to severe postoperative pain in hospital settings in adult patients.
The SSTS is non-invasive and imposes no restrictions on patient mobility, which renders it particularly suitable for clinical conditions where early mobilization is a key component of successful surgical outcome.
The present study tests the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
The SSTS is non-invasive and imposes no restrictions on patient mobility, which renders it particularly suitable for clinical conditions where early mobilization is a key component of successful surgical outcome.
The present study tests the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
Detailed Description:
Total knee arthroplasty is one of the most common major procedures performed today with a significant impact on health care budgets. Fast track rehabilitation programmes are being developed to control hospitalization costs associated with this procedure. Interestingly, such pathway controlled fast track programs also appear to enhance functional recovery and to reduce complications. These beneficial effects are mainly attributed to the practice of rapid mobilization and early intensified physiotherapy which can only be achieved with effective analgesic techniques.
Current PCA techniques - predominantly morphine based - are the gold standard for this purpose but they involve intravenous access and a programmable computer system requiring close supervision. Reported shortcomings are systems failure leading to analgesic gaps, drug errors and restrictions in mobility since patients are tethered to IV poles. The SSTS may overcome these limitations because the opioid used, sufentanil, has a more predictable time of onset, the delivery system does not require programming, and the device does not limit patient's mobility. It retains the benefits of potent analgesia as well as patient empowerment and is particularly suited to target the analgesic effect precisely to the level required in physiotherapeutic sessions.
The present study will test the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
The study will focus on the efficiency of STSS which is defined as 75% or more of the treated patients proves NRS score less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).
The STSS will allow the patient tot take a maximum of 3 doses in one hour. Treatment with the STSS is continued over a period of 48 hours or if necessary up to 72 hours.
During this period the patients pain en parameters will be monitored closely.
The maximum administered total dose of Zalviso will not exceed 1.2mg.
Current PCA techniques - predominantly morphine based - are the gold standard for this purpose but they involve intravenous access and a programmable computer system requiring close supervision. Reported shortcomings are systems failure leading to analgesic gaps, drug errors and restrictions in mobility since patients are tethered to IV poles. The SSTS may overcome these limitations because the opioid used, sufentanil, has a more predictable time of onset, the delivery system does not require programming, and the device does not limit patient's mobility. It retains the benefits of potent analgesia as well as patient empowerment and is particularly suited to target the analgesic effect precisely to the level required in physiotherapeutic sessions.
The present study will test the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
The study will focus on the efficiency of STSS which is defined as 75% or more of the treated patients proves NRS score less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).
The STSS will allow the patient tot take a maximum of 3 doses in one hour. Treatment with the STSS is continued over a period of 48 hours or if necessary up to 72 hours.
During this period the patients pain en parameters will be monitored closely.
The maximum administered total dose of Zalviso will not exceed 1.2mg.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: