Clinical trial NCT03459404: Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Spinal Fusion
Spondylolisthesis, Lumbar Region
Sufentanil
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients who met the inclusion criteria and were operated in Policlinico A. Gemelli from September 2017 to February 2018.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria:

* Patients who refused to participate in the study.

Primary outcomes:
measure: Postoperative pain intensity assessed at 24 hours
timeFrame: NRS-11 is assessed at 24 hours.
Secondary outcomes:
measure: Postoperative pain intensity assessed at 48 hours
timeFrame: NRS-11 is assessed at 48 hours.
measure: Patient satisfaction
timeFrame: At discharge (at least 48 hours)
measure: Side effects
timeFrame: During the period of SSTS administration (up to 72 hours)
measure: Length of hospital stay after surgery
timeFrame: At least 48 hours
measure: Postoperative pain intensity assessed at 72 hours
timeFrame: NRS-11 is assessed at 72 hours.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome
name: Alessandro Vergari
role: PRINCIPAL_INVESTIGATOR
References: