Safety and Efficacy of Patient Controlled Analgesia using the Sublingual Sufentanil Tablet System (SSTS) in a fast track rehabilitation program after Total Knee Arthroplasty.

Phase 1

• Conditions: Total Knee Arthroplasty; MedDRA version: 21.1Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001232-59-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-20
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Consenting male and female patients
between the age of 40 – 75 years, who are admitted for
elective total knee arthroplasty, qualify for a fast track rehabilitation program with early mobilization and early hospital discharge, understand the Patient controlled analgesia (PCA) principle and are capable to operate the SSTS device.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

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
-hypersensitivity to sufentanil
-significant respiratory depression (need for outpatient supplemental oxygen therapy),
-participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified