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

NCT03459404 | Completed

• 1 other identifier: ZLV022018
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Spinal Fusion; Spondylolisthesis, Lumbar Region; Sufentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain intensity assessed at 48 hours

  NRS-11 is assessed at 48 hours.

• Patient satisfaction

  At discharge (at least 48 hours)

• Side effects

  During the period of SSTS administration (up to 72 hours)

• Length of hospital stay after surgery

  At least 48 hours

• Postoperative pain intensity assessed at 72 hours

  NRS-11 is assessed at 72 hours.

Study Arms (1)

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

Interventions

Sufentanil NanoTab PCA System COMBINATION_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

Sufentanil NanoTab PCA System/15 mcg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who refused to participate in the study.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico A. Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Spondylolisthesis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Alessandro Vergari

  Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 8, 2018
• Study Start: September 19, 2018
• Primary Completion: March 10, 2019
• Study Completion: March 10, 2019
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

IT (1)