NCT03459404

Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation

Completed Last updated 23 August 2021

What this trial tests

trial testing Sufentanil NanoTab PCA System in Postoperative Pain in 17 participants. Completed in 10 March 2019.

Timeline

19 September 2018

Primary endpoint
10 March 2019

10 March 2019

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Completed
Study type	OBSERVATIONAL
Enrollment	17
Start date	19 September 2018
Primary completion	10 March 2019
Estimated completion	10 March 2019
Sites	1 location across Italy

Drugs / interventions tested

• Sufentanil NanoTab PCA System

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Spinal Fusion — all drugs for Spinal Fusion →
• Spondylolisthesis, Lumbar Region — all drugs for Spondylolisthesis, Lumbar Region →
• Sufentanil — all drugs for Sufentanil →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 18 to 75, any sex, with Postoperative Pain or Spinal Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.