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: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Sufentanil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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