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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001232-59-BE

Enrollment

156

Registered

2019-11-20

Start date

2020-01-29

Completion date

Unknown

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty MedDRA version: 21.1 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Zalviso 15 microgram tabletten voor sublinguaal gebruik. Pharmaceutical Form: Sublingual tablet INN or Proposed INN: SUFENTANIL CITRATE CAS Number: 60561-17-3 Concentration unit: µg microg

Eligibility

Sex/Gender

All

Inclusion 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

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 (eGFR15mg 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficiency of Sublingual Sufentanil Tablet System (SSTS) which is defined as 75% or more of the treated patients proves NRS less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).;Secondary Objective: Safety of the SSTS based on the amount and type of side effects, classified conform NIH criteria (CTCAE) (National institute of health criteria (common terminology criteria for adverse events)) and the risk of causal relationship with the treatment Level of analgesia during physiotherapy. ;Primary end point(s): Cumulative/total time when NRS<4 during 48 hours postoperatively.;Timepoint(s) of evaluation of this end point: During 48 hours postoperatively.	—

Measure

Time frame

Main Objective: Efficiency of Sublingual Sufentanil Tablet System (SSTS) which is defined as 75% or more of the treated patients proves NRS less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).;Secondary Objective: Safety of the SSTS based on the amount and type of side effects, classified conform NIH criteria (CTCAE) (National institute of health criteria (common terminology criteria for adverse events)) and the risk of causal relationship with the treatment Level of analgesia during physiotherapy. ;Primary end point(s): Cumulative/total time when NRS<4 during 48 hours postoperatively.;Timepoint(s) of evaluation of this end point: During 48 hours postoperatively.

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Secondary

Measure	Time frame
Secondary end point(s): - length of hospital stay - nausea - vomiting - itching - drowsiness - constipation - desaturation - evaluation by health care workers (nurses, physiotherapists) - evaluation by the patient - consumption of study medicadtion during study period for each patient ;Timepoint(s) of evaluation of this end point: During 48 hours postoperatively.	—

Countries

Belgium

Contacts

Public ContactHIRUZ CTU

Ghent University Hospital

Hiruz.ctu@uzgent.be+3293320520

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026