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

Completed

• Conditions: Postoperative Pain; Sufentanil; Spondylolisthesis, Lumbar Region; Spinal Fusion
• Interventions: Combination Product: Sufentanil NanoTab PCA System

• Registration Number: NCT03459404
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-09-19
• Primary Completion: 2019-03-10
• Study Completion: 2019-03-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sufentanil NanoTab PCA System/15 mcg	Sufentanil NanoTab PCA System	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).

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity assessed at 24 hours	NRS-11 is 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'.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico A. Gemelli; 🇮🇹 Rome, Italy