Postoperative PainNCT03459404
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
An observational study of Postoperative Pain and Spinal Fusion, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the management of acute moderate-to-severe pain in adult patients in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Spinal Fusion, Spondylolisthesis, Lumbar Region
- What is being tested?
- Sufentanil NanoTab PCA System
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 19 Sep 2018to 10 Mar 2019
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients who met the inclusion criteria and were operated in Policlinico A. Gemelli from September 2017 to February 2018.
Who may be able to join
- Patients who underwent elective open lumbar arthrodesis surgery (either by an anterior or posterior approach) in degenerative lumbar spine conditions who were between 18 and 75 years old and post-operatively treated with Sufentanil NanoTab PCA system as part of a multimodal analgesic regimen.
- General anesthesia was performed. Perioperative regional anesthetic techniques and local anesthetic wound infiltration in the operating room were not performed.
Who cannot join
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-institution Case-series Analysis on the Addition of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to a Multimodal Analgesic Regimen in Vertebral Surgery: A Preliminary Investigation
The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the management of acute moderate-to-severe pain in adult patients in a hospital setting. This preprogrammed drug/device combination product delivers a fixed dose of 15 mcg of sufentanil tablets as needed, in a non-invasive sublingual dosage form.
Multimodal analgesia is defined as the administration, by one or more routes, of various analgesic medications with different mechanisms of action, thereby providing superior analgesia with fewer side effects. To improve pain control and patient satisfaction, patient-controlled analgesia (PCA) techniques have been developed, i.e. any delivery system which allows patients to self administer predetermined doses of analgesic drug to relieve pain. Over the past decades, intravenous (IV) PCA with morphine has been the gold standard for acute pain control. In our clinical practice, though, not only IV-PCA pumps were frequently prone to technical problems, but also patients and caregivers were not often able to understand or activate them, thus raising important safety issues and profoundly affecting the management of pain control. As a consequence, IV-PCA eventually fell into disuse, although no alternative has emerged until recently. The SSTS should go beyond the above-quoted limitations: it is a non invasive, patient-controlled and easy to use device, with an effective and safe opioid profile. It is, in our thinking, a promising technology.
The aim of this retrospective analysis is to examine the role of the SSTS for management of pain after vertebral surgery, as part of a multimodal approach.
- Being tested
- Sufentanil NanoTab PCA System
- Medical subject headings
- Pain, Postoperative, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil NanoTab PCA SystemCombination product
15 mcg Sufentanil NanoTab self-administered sublingually up to every 20 minutes as needed for pain for at least 48 hours and up to 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Drug: Sufentanil 15 mcg
Unless contraindicated patients also received around the clock regimen of NSAIDS (ketoprofen 200 mg/day) and acetaminophen (1000 mg every 8 hours). Receives: Combination Product: Sufentanil NanoTab PCA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed at 24 hours
Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS-11). It ranges from '0' representing 'no pain' to '10' representing 'the worst pain imaginable'.
Measured: NRS-11 is assessed at 24 hours.
Secondary outcomes (5)
Postoperative pain intensity assessed at 48 hours
Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS-11). It ranges from '0' representing 'no pain' to '10' representing 'the worst pain imaginable'.
Measured: NRS-11 is assessed at 48 hours.
Patient satisfaction
Satisfaction with level of pain control and satisfaction with method of administration of pain medication are scored on a 4-point scale (extremely dissatisfied to extremely satisfied).
Measured: At discharge (at least 48 hours)
Side effects
Nausea, vomiting, sleepiness, itching, dizziness, others
Measured: During the period of SSTS administration (up to 72 hours)
Length of hospital stay after surgery
Variable, depending on clinical case
Measured: At least 48 hours
Postoperative pain intensity assessed at 72 hours
Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS-11). It ranges from '0' representing 'no pain' to '10' representing 'the worst pain imaginable'.
Measured: NRS-11 is assessed at 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start19 Sep 2018
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Alessandro Vergari, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459404
- Sponsor's protocol ID
- ZLV022018
- Status last verified
- Aug 2021
- First submitted
- 20 Feb 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-institution Case-series Analysis on the Addition of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to a Multimodal Analgesic Regimen in Vertebral Surgery: A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT03459404
- Acronym / sponsor ID
- ZLV022018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 8 Mar 2018 (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 Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the management of acute moderate-to-severe pain in adult patients in a hospital setting. This preprogrammed drug/device combination product delivers a fixed dose of 15 mcg of sufentanil tablets as needed, in a non-invasive sublingual dosage form.
Multimodal analgesia is defined as the administration, by one or more routes, of various analgesic medications with different mechanisms of action, thereby providing superior analgesia with fewer side effects. To improve pain control and patient satisfaction, patient-controlled analgesia (PCA) techniques have been developed, i.e. any delivery system which allows patients to self administer predetermined doses of analgesic drug to relieve pain. Over the past decades, intravenous (IV) PCA with morphine has been the gold standard for acute pain control. In our clinical practice, though, not only IV-PCA pumps were frequently prone to technical problems, but also patients and caregivers were not often able to understand or activate them, thus raising important safety issues and profoundly affecting the management of pain control. As a consequence, IV-PCA eventually fell into disuse, although no alternative has emerged until recently. The SSTS should go beyond the above-quoted limitations: it is a non invasive, patient-controlled and easy to use device, with an effective and safe opioid profile. It is, in our thinking, a promising technology.
The aim of this retrospective analysis is to examine the role of the SSTS for management of pain after vertebral surgery, as part of a multimodal approach.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | – | Combination Product: Sufentanil NanoTab PCA SystemDrug: Sufentanil 15 mcg Unless contraindicated patients also received around the clock regimen of NSAIDS (ketoprofen 200 mg/day) and acetaminophen (1000 mg every 8 hours). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who met the inclusion criteria and were operated in Policlinico A. Gemelli from September 2017 to February 2018.
Key inclusion criteria (2 listed)
- Patients who underwent elective open lumbar arthrodesis surgery (either by an anterior or posterior approach) in degenerative lumbar spine conditions who were between 18 and 75 years old and post-operatively treated with Sufentanil NanoTab PCA system as part of a multimodal analgesic regimen.
- General anesthesia was performed. Perioperative regional anesthetic techniques and local anesthetic wound infiltration in the operating room were not performed.
Key exclusion criteria (1 listed)
- Patients who refused to participate in the study.
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 NanoTab PCA System15 mcg Sufentanil NanoTab self-administered sublingually up to every 20 minutes as needed for pain for at least 48 hours and up to 72 hours | Combination product | Sufentanil NanoTab PCA System/15 mcg |
Primary outcome
Postoperative pain intensity assessed at 24 hours
Time frame: NRS-11 is assessed at 24 hours.
Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS-11). It ranges from '0' representing 'no pain' to '10' representing 'the worst pain imaginable'.
5 secondary outcomes
Postoperative pain intensity assessed at 48 hours
Time frame: NRS-11 is assessed at 48 hours.
Patient satisfaction
Time frame: At discharge (at least 48 hours)
Side effects
Time frame: During the period of SSTS administration (up to 72 hours)
Length of hospital stay after surgery
Time frame: At least 48 hours
Postoperative pain intensity assessed at 72 hours
Time frame: NRS-11 is assessed at 72 hours.
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 23 Aug 2021.
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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.
Alessandro Vergari principal investigator
Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Spinal Fusion, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 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 23 Aug 2021. 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 Italy. 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?
Postoperative pain intensity assessed at 24 hours (time frame: NRS-11 is assessed at 24 hours.). 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 23 Aug 2021.