An observational study in Postoperative Pain, Spinal Fusion and Spondylolisthesis, Lumbar Region, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Among 115 studies in Pain, Postoperative with a site in Italy — 18 open to participants now, 21 under way, none of them phase 3. Pain, Postoperative · Italy.
Among the 115 studies in Pain, Postoperative with a site in Italy, this one is the 29th largest by enrollment of the 29 observational ones that give a count, is one of 6 that started in 2018, is one of 29 observational ones, and was the 41st registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →18 of the 115 studies in Pain, Postoperative with a site in Italy are open now. Recruiting first, the newest first:
University of Rome Tor Vergata · Sites in Italy
ASST Sette Laghi · Sites in Italy
ASST Gaetano Pini-CTO · Sites in Italy
A.O.U. Città della Salute e della Scienza · Sites in Italy
AUSL Romagna Rimini · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
115 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 7 · Phase 4 11
First in 2006; this study’s year is marked. 6 started in 2018.
This study's enrollment of 17 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Median enrollment 79 across the 86 interventional studies, 120 across the 29 observational. Of the 71 that completed or were terminated, 6 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 115 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 8 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
6 of the studies in Pain, Postoperative with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06182059Policlinico di Monza SpAPersistent Post Surgical Pain After Total Knee Arthroplasty | 2027-01-31 |
| NCT07831096ASST Sette LaghiAnterior Suprascapular Versus Interscalene Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery in the Outpatient Setting | 2027-02 |
| NCT06244732IRCCS Policlinico S. DonatoPain Control After Aortic EndoaneurYsmEctomy (POPEYE) | 2027-02 |
| NCT07239817ASST Gaetano Pini-CTOPENG Block + LIA For Endoprosthesis Surgery | 2027-02-28 |
| NCT07250373Fondazione Policlinico Universitario Agostino Gemelli IRCCSSerratus Posterior Superior Intercostal Plane (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal-VATS. | 2027-04-30 |
Among the 115 studies in Pain, Postoperative with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Consecutive patients who met the inclusion criteria and were operated in Policlinico A. Gemelli from September 2017 to February 2018.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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).
Combination Product: Sufentanil NanoTab PCA System
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
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'.
Time frame: NRS-11 is assessed at 24 hours.
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'.
Time frame: 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).
Time frame: At discharge (at least 48 hours)
Side effects
Nausea, vomiting, sleepiness, itching, dizziness, others
Time frame: During the period of SSTS administration (up to 72 hours)
Length of hospital stay after surgery
Variable, depending on clinical case
Time frame: 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'.
Time frame: NRS-11 is assessed at 72 hours.
Ran from Sep 2018 to primary completion in Mar 2019, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →