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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Spinal Fusion; Spondylolisthesis, Lumbar Region; Sufentanil
• Intervention / Treatment: Combination product: Sufentanil NanoTab PCA System

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Policlinico A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	NRS-11 is assessed at 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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).	At discharge (at least 48 hours)
Side effects	Nausea, vomiting, sleepiness, itching, dizziness, others	During the period of SSTS administration (up to 72 hours)
Length of hospital stay after surgery	Variable, depending on clinical case	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'.	NRS-11 is assessed at 72 hours.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Alessandro Vergari, Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): March 10, 2019

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: ZLV022018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No