Postoperative PainPhase 4ZalvisoNCT04432428
Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
A Phase 4 study testing Sufentanil Sublingual Tablet in people with Postoperative Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sufentanil Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2020to 19 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Sufentanil Sublingual Tablet
- Keywords
- knee surgery, Patient Controlled Analgesia (PCA), Enhansed Recovery After Surgery (ERAS)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil Sublingual TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| sufentanil sublingual tablet | Experimental | sufentanil sublingual 15µg tablets Receives: Drug: Sufentanil Sublingual Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time NRS<4
cumulative time that patient had NRS<4
Measured: from end of surgery until 48 hours postoperatively
Secondary outcomes (11)
length of hospital stay
amount of days that patient was admitted to the hosptial
Measured: from hospital admission until hospital discharge, up to 1 week post-operatively
Incidence of the side effect nausea
Incidence of the side effect nausea with a simple scale (none, mild, moderate, severe)
Measured: from end of surgery until 72 hours postoperatively
Incidence of the side effect vomiting
Incidence of the side effect vomiting with a simple scale (none, mild, moderate, severe)
Measured: from end of surgery until 72 hours postoperatively
Incidence of the side effect itching
Incidence of the side effect itching with a simple scale (none, mild, moderate, severe)
Measured: from end of surgery until 72 hours postoperatively
Incidence of the side effect drowsiness
Incidence of the side effect drowsiness with a simple scale (none, mild, moderate, severe)
Measured: from end of surgery until 72 hours postoperatively
Incidence of the side effect constipation
Incidence of the side effect constipation with a simple scale (none, mild, moderate, severe)
Measured: from end of surgery until 72 hours postoperatively
Oxygen desaturation
Oxygen desaturation
Measured: from end of surgery until 72 hours postoperatively
patient satisfaction with Zalviso PCA
patient satisfaction assessed with patient ease of care questionnaire
Measured: 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
health care worker satisfaction assessed with nurse/physical therapist ease of care questionnaire
Measured: after patients discontinuation of study medication, up to 1 week after stop study medication
consumption of study medication
total amount of study medication that was administered
Measured: 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
Level of analgesia during physiotherapy assessed with NRS scale
Measured: from start until end of physiotherapy session, up to 2 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start26 May 2020
- Primary completion31 Aug 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentric interventional prospective cohort study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wouters, MD PhD, Principal investigator, University Hospital, GhentLuc Verbacnk, MD, Principal investigator, Yperman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432428
- Sponsor's protocol ID
- 2019/1741
- Acronym
- Zalviso
- Status last verified
- Jan 2020
- First submitted
- 8 Jun 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04432428
- Acronym / sponsor ID
- Zalviso / 2019/1741
- Conditions
- Postoperative Pain
- Keywords
- knee surgery, Patient Controlled Analgesia (PCA), Enhansed Recovery After Surgery (ERAS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentric interventional prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| sufentanil sublingual tablet | Experimental | Drug: Sufentanil Sublingual Tabletsufentanil sublingual 15µg tablets |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Outside age range
- Contra indication for anti-inflammatory drugs
- Revision total knee arthroplasty
- history of substance abuse,
- pregnancy,lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil Sublingual Tabletall 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 | Drug | sufentanil sublingual tablet |
Primary outcome
Total time NRS<4
Time frame: from end of surgery until 48 hours postoperatively
cumulative time that patient had NRS<4
11 secondary outcomes
length of hospital stay
Time frame: 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 vomiting
Time frame: 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 drowsiness
Time frame: from end of surgery until 72 hours postoperatively
Incidence of the side effect constipation
Time frame: from end of surgery until 72 hours postoperatively
Oxygen desaturation
Time frame: 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
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
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
Level of analgesia during physiotherapy
Time frame: from start until end of physiotherapy session, up to 2 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Wouters, MD PhD principal investigator
University Hospital, Ghent
Luc Verbacnk, MD principal investigator
Yperman Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil Sublingual Tablet in people with Postoperative Pain, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time NRS<4 (time frame: from end of surgery until 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.