Pain, PostoperativeNCT03036514
Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
A study testing Sublingual sufentanil tablet system in people with Pain, Postoperative, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Sublingual sufentanil tablet system
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Apr 2017to 1 Sep 2019
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled elective laminectomy or spinal fusion
- American Society Anesthesiology Classification system (ASA) I-III
Who cannot join
- chronic opioid use (>3 months)
- pregnancy
- obstructive sleep apnea syndrome
- supplemental oxygen therapy at home
- postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia (PCIA) With Morphine for Postoperative Pain After Back Surgery. A Single Center Case-control Study.
In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).
Read the detailed description
Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the postoperative phase after back surgery. The common use of PCIA with morphine is associated with a rather slow onset-time and active metabolites, with occurrence of potential harmful side effects as sedation and desaturation.
This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited. Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the first 72h postoperatively.
- Conditions
- Pain, Postoperative
- Being tested
- Sublingual sufentanil tablet system, Patient-controlled intravenous analgesia
- Keywords
- numeric rating scale, opioid side effects
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual sufentanil tablet systemDevice
Also called SSTS, Zalviso
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
Patient-controlled intravenous analgesiaDrug
Also called PCIA
Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Sublingual sufentanil tablet system (SSTS) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. Orange-coloured tablets containing 15mcg sufentanil, the patient-controlled device is designed to deliver a single tablet with a minimum lockout interval of 20 minutes. Receives: Device: Sublingual sufentanil tablet system |
| Control | Active comparator | Patient-controlled intravenous analgesia (PCIA) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. This classic patient-controlled IV-pump contains 1mg/ml morphine and 50mcg/ml dehydrobenzperidol. Pump characteristics include 1ml each asked bolus, lockout interval of 8 minutes. Receives: Drug: Patient-controlled intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
Pain assessment by NRS
Measured: 72 hours postoperatively
Secondary outcomes (1)
Evaluation of side effect
Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start5 Apr 2017
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single center case-control study design
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
- Investigators
- Davina Wildemeersch, MD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036514
- Sponsor's protocol ID
- 16/45/479
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia (PCIA) With Morphine for Postoperative Pain After Back Surgery. A Single Center Case-control Study.
- ClinicalTrials.gov ID
- NCT03036514
- Acronym / sponsor ID
- 16/45/479
- Conditions
- Pain, Postoperative
- Keywords
- numeric rating scale, opioid side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- 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.
In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).
Detailed description
Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the postoperative phase after back surgery. The common use of PCIA with morphine is associated with a rather slow onset-time and active metabolites, with occurrence of potential harmful side effects as sedation and desaturation.
This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited. Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the first 72h postoperatively.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center case-control study design
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Device: Sublingual sufentanil tablet systemSublingual sufentanil tablet system (SSTS) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. Orange-coloured tablets containing 15mcg sufentanil, the patient-controlled device is designed to deliver a single tablet with a minimum lockout interval of 20 minutes. |
| Control | Active comparator | Drug: Patient-controlled intravenous analgesiaPatient-controlled intravenous analgesia (PCIA) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. This classic patient-controlled IV-pump contains 1mg/ml morphine and 50mcg/ml dehydrobenzperidol. Pump characteristics include 1ml each asked bolus, lockout interval of 8 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled elective laminectomy or spinal fusion
- American Society Anesthesiology Classification system (ASA) I-III
Key exclusion criteria (5 listed)
- chronic opioid use (>3 months)
- pregnancy
- obstructive sleep apnea syndrome
- supplemental oxygen therapy at home
- postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs
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 |
|---|---|---|
| Sublingual sufentanil tablet systemAlso: SSTS, ZalvisoUsage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion. | Device | Case |
| Patient-controlled intravenous analgesiaAlso: PCIAUsage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion. | Drug | Control |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 72 hours postoperatively
Pain assessment by NRS
1 secondary outcome
Evaluation of side effect
Time frame: 72 hours postoperatively
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 9 Mar 2020.
- 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.
Davina Wildemeersch, MD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublingual sufentanil tablet system in people with Pain, Postoperative, run by University Hospital, Antwerp 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 2 inclusion and 5 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 9 Mar 2020. 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.
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?
Numeric Rating Scale (NRS) (time frame: 72 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 9 Mar 2020.