"Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Postoperative pain control
研究概览
简要总结
Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.
详细描述
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour.
45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent signed;
- •Age superior to 18 years;
- •Physical status according to the American Society of Anesthesiology (ASA) 1-3;
- •Scheduled gynecological surgery: abdominal hysterectomy
- •Scheduled orthopedic surgery: total knee arthroplasty or total hip arthroplasty.
排除标准
- •Patient refusal to participate in the study;
- •Age <18 years or legal dependence;
- •Neurological or psychiatric pathology or altered state of consciousness that does not allow for the Patient Controlled Analgesia strategy;
- •Documented drinking habits and/or consumption of illicit drugs;
- •Patients tolerant to opioid therapy (use of >15 mg oral morphine or its equivalent per day for the last 3 months);
- •Documented obstructive Sleep Apnea Syndrome (OSAS);
- •Patients on long-term oxygen therapy;
- •Intraoperative use of intrathecal morphine;
- •Use of anesthetic techniques in order to provide postoperative analgesia (eg, epidural catheter; peripheral nerve block; infiltration of the surgical wound with local anesthetic).
研究组 & 干预措施
Sufentanil Sublingual Tablet System
Group treated with Sufentanil Sublingual Tablet System
干预措施: Sufentanil Sublingual Tablet System (Drug)
Intravenous Patient-Controlled Analgesia with Morphine
Group treated with intravenous Patient-Controlled Analgesia with Morphine
干预措施: Intravenous Patient-Controlled Analgesia with morfine (Drug)
结局指标
主要结局
Postoperative pain control
时间窗: Evaluation at 24 hours and 48 hours after surgery
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale
次要结局
- Adverse effects associated with analgesia(Evaluation at 24 hours and 48 hours after surgery)
- Total daily dose of opioid(Evaluation at 24 hours and 48 hours after surgery)
- Patients satisfaction with analgesia(Evaluation at 24 hours and 48 hours after surgery)
- Impact of the treatment on the quality of postoperative recovery(Evaluation at 24 hours after surgery)
- Incidence of postoperative chronic pain(4 months after surgey)
研究者
Ana isabel freitas amorim
Ana Isabel Freitas Amorim
Hospital Central do Funchal