Status:
COMPLETED
Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Lead Sponsor:
University Hospital, Ghent
Conditions:
Postoperative Pain
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 adul...
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...
Eligibility Criteria
Inclusion
- Male and female patients between 40-75 years old
- Able to give consent
- Scheduled of elective knee arthroplasty with a fast rehabilitation program
- Able to understand PCA principle and capable to operate SSTS device
Exclusion
- Outside age range
- Contra indication for anti-inflammatory drugs
- Revision total knee arthroplasty
- history of substance abuse,
- pregnancy,lactation
- severe hepatic impairment (INR\>1,5 and/or AST/ALT above x3 highest normal value),
- sleep apnea (documented by sleep laboratory study),
- severe chronic kidney disease (eGFR\<30 mL/min/1.73 m2),
- severe and very severe COPD (GOLD III and IV)
- opioid tolerance (use of \>15mg oral morphine equivalent per day within the past 3 months),
- chronic pain conditions necessitating gabapentinoids, steroids or anti-inflammatory drugs
- hypersensitivity to sufentanil
- significant respiratory depression (need for outpatient supplemental oxygen therapy),
- participation in another clinical trial
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04432428
Start Date
May 26 2020
End Date
September 19 2021
Last Update
December 6 2022
Active Locations (1)
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1
University Hospital Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000