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Clinical Trials/EUCTR2019-001232-59-BE
EUCTR2019-001232-59-BE
Active, not recruiting
Phase 1

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

Ghent University Hospital0 sites156 target enrollmentNovember 20, 2019
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ConditionsTotal Knee ArthroplastyMedDRA version: 21.1Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsZalviso 15 microgram tabletten voor sublinguaal gebruik.

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Ghent University Hospital
Enrollment
156
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2019
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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),

Outcomes

Primary Outcomes

Not specified

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