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临床试验/NCT03459404
NCT03459404已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Postoperative pain intensity assessed at 24 hours

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Postoperative pain intensity assessed at 24 hours

时间窗: 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'.

次要结局

  • Postoperative pain intensity assessed at 48 hours(NRS-11 is assessed at 48 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.)
  • Patient satisfaction(At discharge (at least 48 hours))
  • Side effects(During the period of SSTS administration (up to 72 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

VERGARI ALESSANDRO

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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