Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total time NRS<4
研究概览
简要总结
The sufentanil sublingual tablet system (SSTS) is an innovative patient-controlled analgesia (PCA) device for the management of acute moderate to severe postoperative pain in hospital settings in adult patients.
The SSTS is non-invasive and imposes no restrictions on patient mobility, which renders it particularly suitable for clinical conditions where early mobilization is a key component of successful surgical outcome.
The present study tests the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
详细描述
Total knee arthroplasty is one of the most common major procedures performed today with a significant impact on health care budgets. Fast track rehabilitation programmes are being developed to control hospitalization costs associated with this procedure. Interestingly, such pathway controlled fast track programs also appear to enhance functional recovery and to reduce complications. These beneficial effects are mainly attributed to the practice of rapid mobilization and early intensified physiotherapy which can only be achieved with effective analgesic techniques.
Current PCA techniques - predominantly morphine based - are the gold standard for this purpose but they involve intravenous access and a programmable computer system requiring close supervision. Reported shortcomings are systems failure leading to analgesic gaps, drug errors and restrictions in mobility since patients are tethered to IV poles. The SSTS may overcome these limitations because the opioid used, sufentanil, has a more predictable time of onset, the delivery system does not require programming, and the device does not limit patient's mobility. It retains the benefits of potent analgesia as well as patient empowerment and is particularly suited to target the analgesic effect precisely to the level required in physiotherapeutic sessions.
The present study will test the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.
The study will focus on the efficiency of STSS which is defined as 75% or more of the treated patients proves NRS score less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).
The STSS will allow the patient tot take a maximum of 3 doses in one hour. Treatment with the STSS is continued over a period of 48 hours or if necessary up to 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 40-75 years old
- •Able to give consent
- •Scheduled of elective knee arthroplasty with a fast rehabilitation program
- •Able to understand PCA principle and capable to operate SSTS device
排除标准
- •Outside age range
- •Contra indication for anti-inflammatory drugs
- •Revision total knee arthroplasty
- •history of substance abuse,
- •pregnancy,lactation
- •severe hepatic impairment (INR>1,5 and/or AST/ALT above x3 highest normal value),
- •sleep apnea (documented by sleep laboratory study),
- •severe chronic kidney disease (eGFR<30 mL/min/1.73 m2),
- •severe and very severe COPD (GOLD III and IV)
- •opioid tolerance (use of >15mg oral morphine equivalent per day within the past 3 months),
- •chronic pain conditions necessitating gabapentinoids, steroids or anti-inflammatory drugs
- •hypersensitivity to sufentanil
- •significant respiratory depression (need for outpatient supplemental oxygen therapy),
- •participation in another clinical trial
研究组 & 干预措施
sufentanil sublingual tablet
sufentanil sublingual 15µg tablets
干预措施: Sufentanil Sublingual Tablet (Drug)
结局指标
主要结局
Total time NRS<4
时间窗: from end of surgery until 48 hours postoperatively
cumulative time that patient had NRS\<4
次要结局
- Incidence of the side effect nausea(from end of surgery until 72 hours postoperatively)
- Incidence of the side effect itching(from end of surgery until 72 hours postoperatively)
- patient satisfaction with Zalviso PCA(after discontinuation of study medication, up to 72 hrs after start of the study medication)
- consumption of study medication(from start administration of study medication until end of administration of study medication, up to a maximum of 72 hrs)
- length of hospital stay(from hospital admission until hospital discharge, up to 1 week post-operatively)
- Incidence of the side effect constipation(from end of surgery until 72 hours postoperatively)
- Incidence of the side effect vomiting(from end of surgery until 72 hours postoperatively)
- Oxygen desaturation(from end of surgery until 72 hours postoperatively)
- Incidence of the side effect drowsiness(from end of surgery until 72 hours postoperatively)
- health care worker satisfaction with the patients pain treatment with Zalviso PCA(after patients discontinuation of study medication, up to 1 week after stop study medication)
- Level of analgesia during physiotherapy(from start until end of physiotherapy session, up to 2 days post-operatively)