Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Hydromorphone consommation
研究概览
简要总结
The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.
详细描述
This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •ASA 1,2 or 3
- •Minimum weight of 50 kg
- •Patient able to consent
排除标准
- •Patient refusal
- •Patient unable to understand PCA
- •Contraindication to rachianalgesia
- •Pregnancy
- •Over 30 mg of morphine during the last 24 hours
- •Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain
- •Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic
- •Intubation over 1 hour after surgery (unability to use PCA)
- •High risk of conversion to thoracotomy
- •Unable to perform rachianalgesia due to technical difficulties
研究组 & 干预措施
Intrathecal Morphine/Sufentanil and PCA
Patients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period.
干预措施: Intrathecal Morphine/Sufentanil (Drug)
Intrathecal Morphine/Sufentanil and PCA
Patients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period.
干预措施: PCA (Device)
PCA alone
Patients will NOT receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will only have a PCA for analgesia in the post-operative period.
干预措施: PCA (Device)
结局指标
主要结局
Hydromorphone consommation
时间窗: 24hr
The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.
次要结局
- Adverse reactions of narcotics(24hr)
- Adverse effects of narcotics(Every 4h x 24hr)
- Pain(Every 4h x 24hr)
- Adverse reactions associate with rachianesthesia(24hr)
研究者
Yanick Sansoucy
Anesthesiologist
Université de Sherbrooke