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
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
- 否
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
VERGARI ALESSANDRO
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
