Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty (Zalviso)

December 3, 2022 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 hospitalization costs associated with this procedure. Interestingly, such pathway controlled fast track programs also appear to enhance functional recovery and to reduce complications. These beneficial effects are mainly attributed to the practice of rapid mobilization and early intensified physiotherapy which can only be achieved with effective analgesic techniques.

Current PCA techniques - predominantly morphine based - are the gold standard for this purpose but they involve intravenous access and a programmable computer system requiring close supervision. Reported shortcomings are systems failure leading to analgesic gaps, drug errors and restrictions in mobility since patients are tethered to IV poles. The SSTS may overcome these limitations because the opioid used, sufentanil, has a more predictable time of onset, the delivery system does not require programming, and the device does not limit patient's mobility. It retains the benefits of potent analgesia as well as patient empowerment and is particularly suited to target the analgesic effect precisely to the level required in physiotherapeutic sessions.

The present study will test the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.

The study will focus on the efficiency of STSS which is defined as 75% or more of the treated patients proves NRS score less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).

The STSS will allow the patient tot take a maximum of 3 doses in one hour. Treatment with the STSS is continued over a period of 48 hours or if necessary up to 72 hours.

During this period the patients pain en parameters will be monitored closely.

The maximum administered total dose of Zalviso will not exceed 1.2mg.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sufentanil sublingual tablet
sufentanil sublingual 15µg tablets

all patients will receive tablets for sublingual use, containing 15 microgram of sufentanil. The sufentanil tablets come in a cartridge (40 tablets) and are administered with a special patient-controlled device that uses thumb tag recognition.

max dose per hour : 3 tablets of 15µg sufentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time NRS<4
Time Frame: from end of surgery until 48 hours postoperatively
cumulative time that patient had NRS<4
from end of surgery until 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: from hospital admission until hospital discharge, up to 1 week post-operatively
amount of days that patient was admitted to the hosptial
from hospital admission until hospital discharge, up to 1 week post-operatively
Incidence of the side effect nausea
Time Frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect nausea with a simple scale (none, mild, moderate, severe)
from end of surgery until 72 hours postoperatively
Incidence of the side effect vomiting
Time Frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect vomiting with a simple scale (none, mild, moderate, severe)
from end of surgery until 72 hours postoperatively
Incidence of the side effect itching
Time Frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect itching with a simple scale (none, mild, moderate, severe)
from end of surgery until 72 hours postoperatively
Incidence of the side effect drowsiness
Time Frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect drowsiness with a simple scale (none, mild, moderate, severe)
from end of surgery until 72 hours postoperatively
Incidence of the side effect constipation
Time Frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect constipation with a simple scale (none, mild, moderate, severe)
from end of surgery until 72 hours postoperatively
Oxygen desaturation
Time Frame: from end of surgery until 72 hours postoperatively
Oxygen desaturation
from end of surgery until 72 hours postoperatively
patient satisfaction with Zalviso PCA
Time Frame: after discontinuation of study medication, up to 72 hrs after start of the study medication
patient satisfaction assessed with patient ease of care questionnaire
after discontinuation of study medication, up to 72 hrs after start of the study medication
health care worker satisfaction with the patients pain treatment with Zalviso PCA
Time Frame: after patients discontinuation of study medication, up to 1 week after stop study medication
health care worker satisfaction assessed with nurse/physical therapist ease of care questionnaire
after patients discontinuation of study medication, up to 1 week after stop study medication
consumption of study medication
Time Frame: from start administration of study medication until end of administration of study medication, up to a maximum of 72 hrs
total amount of study medication that was administered
from start administration of study medication until end of administration of study medication, up to a maximum of 72 hrs
Level of analgesia during physiotherapy
Time Frame: from start until end of physiotherapy session, up to 2 days post-operatively
Level of analgesia during physiotherapy assessed with NRS scale
from start until end of physiotherapy session, up to 2 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick Wouters, MD PhD, University Hospital, Ghent
  • Principal Investigator: Luc Verbacnk, MD, Yperman Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 19, 2021

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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