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

• ClinicalTrials.gov Identifier: NCT03459404
• Recruitment Status: Completed
• First Posted: March 8, 2018
• Last Update Posted: August 23, 2021
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Information provided by (Responsible Party): VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description

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.

Condition or disease	Intervention/treatment
Postoperative Pain; Spinal Fusion; Spondylolisthesis, Lumbar Region; Sufentanil	Combination Product: Sufentanil NanoTab PCA System

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: September 19, 2018
• Actual Primary Completion Date: March 10, 2019
• Actual Study Completion Date: March 10, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Postoperative pain intensity assessed at 24 hours [ Time Frame: 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 :

1. Postoperative pain intensity assessed at 48 hours [ Time Frame: 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'.
2. Patient satisfaction [ Time Frame: 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).
3. Side effects [ Time Frame: During the period of SSTS administration (up to 72 hours) ]
   Nausea, vomiting, sleepiness, itching, dizziness, others
4. Length of hospital stay after surgery [ Time Frame: At least 48 hours ]
   Variable, depending on clinical case
5. Postoperative pain intensity assessed at 72 hours [ Time Frame: 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'.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes 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.

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.

Contacts and Locations

Locations

Italy

Policlinico A. Gemelli

Rome, Italy, 00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Alessandro Vergari; Department of Anesthesiology and Intensive Care Medicine, Fondazione Policlinico A. Gemelli, Rome

More Information

• Responsible Party: VERGARI ALESSANDRO, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT03459404
• Other Study ID Numbers: ZLV022018
• First Posted: March 8, 2018
• Last Update Posted: August 23, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spondylolisthesis; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Sufentanil; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics