Does Patient-Controlled Epidural Bupivacaine-Fentanyl Offer Advantages Over Continuous Epidural Infusion After Uterine Arteries Embolization? A Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Cumulative consumption of bupivacaine-fentanyl
研究概览
简要总结
Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata through induction of infarction and subsequent hyaline degeneration. This could be followed with variable severity of pain that lasts for several days after the procedure secondary to the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been described as moderate to severe cramping increasing over the first 2 hours after UAE to reach plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of pain is unpredictable.1
Pain management after UAE most often consists of a combination of a non-steroidal anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following embolization of the uterine arteries may require large doses of parenteral opioids for relief with added unwanted effects.2
Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA) after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine consumption for the first 24 hours after UAE. 2
Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic choice for uterine artery embolization as it improves patients satisfaction and reduces the severity of post-procedural pain.
Although some investigators suggest an epidural analgesia for pain control after UAE,4 the use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain management after UAE.5
Thus in an observational study included few patients, the investigators demonstrated considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the catheterization of thoracic epidural space in such low-risk patients has many logistic issues.
Up to the best of our knowledge, there is no available comparative randomized clinical trial compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.
详细描述
The investigators hypothesize that the use of a patient-controlled lumbar epidural analgesia (PCEA) will reduce pain scores and improve patient's satisfaction after uterine artery embolization.
The present study is aiming to compare the efficacy of PCEA and continuous epidural infusion of bupivacaine 0.125% with fentanyl 2 µg/ml on the quality of postoperative analgesia after UAE. Furthermore, the investigators aim to study the correlations between the severity of pain after UAE and the number and size of uterine leiomyomata.
Following obtaining of the Local Ethics Committee approval and informed patient consent, sixty patients, aged 18years or older, undergoing routine elective UAE embolization for uterine leiomyomata under epidural anesthesia will be included in this prospective, randomized, controlled, double-blind, comparative study.
On the morning before embolization, the patients will be instructed in the use of the PCA pump and a VAS. The patients will be asked to rate their experienced pain using the VAS from 0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain.
Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors includes electrocardiograph, non-invasive blood pressure, peripheral oxygen saturation, and respiratory rate. All patients will be premedicated with iv midazolam 0.03 mg/kg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Routine elective uterine artery embolization
- •uterine leiomyomata
- •Epidural anesthesia
排除标准
- •Cardiac disorder
- •Pulmonary disorder
- •Renal disorder
- •Hepatic disorder
- •Neuropsychiatric disorder
- •Bleeding disorder
- •Severe anatomical abnormalities of the vertebral column
- •Contraindications to epidural analgesia
- •Preoperative pain score > 70 mm
- •Drug abuse
- •Daily intake of analgesics
- •Language or mental disorders
结局指标
主要结局
Cumulative consumption of bupivacaine-fentanyl
时间窗: 24 hours after procedure
The cumulative consumption of bupivacaine-fentanyl for 24 hours after uterine artery embolization (UAE) will be recorded
次要结局
- Cumulated amounts of local anesthetic consumption(24 hours after procedure)
- Number of supplementary top-up doses required(24 hours after surgery)
- Uterine leiomyomata(24 hours before uterine artery embolization)
- Time for first request for rescue analgesia(6 hours after surgery)
- Quality of analgesia(every 2 hours intervals after uterine artery embolization)
- Overall patient satisfaction(24 hours after surgery)