Prospective Randomized Study to Measure the Effect of Bilateral Transversus Abdominis Plane (TAP) Block in the Analgesic Control of Patients With Acute Pancreatitis (AP) and Uncontrolled Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- Change of pain levels (VAS) after the intervention
研究概览
简要总结
Background Severe abdominal pain is a hallmark of acute pancreatitis (AP). A control pain is often difficult. Transversus Abdominis Plane (TAP) block has been used in pain control in patients with exacerbation of chronic pancreatitis.
Objectives To evaluate the effect of Bilateral Blockade of the Abdominal Transverse Muscle Plane (TAP Block) in the analgesic control of patients with acute pancreatitis; compared to standard intravenous analgesia.
Methods A randomized controlled trial of parallel groups will be conducted. The Study will have a multicenter development. Study population: Adult patients admitted for episode of AP, with uncontrolled pain (visual analogue scale (VAS) equal to or greater than 5 after the administration of standard analgesia. Randomization Groups: Group A: Patients who will undergo TAP block as analgesic procedure added to standard analgesia. Group B: Patients to whom morphine 2 mg / ev will be administered as analgesic procedure added to standard analgesia.
Timing of pain determination (Visual Analogue Scale, VAS):
- Before conventional analgesia
- Immediately before Randomization
- 15 minutes after the administration of the analgesic treatment object of the study.
- One hour after the procedure.
- Every 8 hours, during the next 4 days or until discharge of the patient.
- Whenever the patient needs a dose of supplemental rescue analgesia. Analysis of data All results will be evaluated according to the initial "intention to treat". There will be a blinded assessment of the results after the last patient in the trial has completed the follow-up. The results will be presented as relative risks with their corresponding confidence intervals. P <0.05 will be considered statistically significant. In case of imbalance between the two treatment groups, a multivariate logistic regression is used to correct possible confounding factors.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute pancreatitis according to modified Atlanta criteria .
- •Patients with the ability to understand the VAS scale and express their level of pain.
- •Patients over 18 years old.
- •Uncontrolled pain, with VAS ≥ 5 after the administration of standard analgesia.
- •Material and technical possibility of performing the TAP technique immediately after randomization.
- •Informed consent of the participating patients for inclusion in the study.
- •Informed consent of the participating patients for the administration of TAP.
- •Normality of coagulation levels
排除标准
- •Patients with American Society of Anaesthesia (ASA) levels IV and V
- •Patients with chronic pancreatitis
- •Pregnancy
- •Patients with chronic treatment with morphic medication
结局指标
主要结局
Change of pain levels (VAS) after the intervention
时间窗: Baseline (Before the intervention), 15 minutes after the intervention, 1 hour after the intervention, 8 hours after the intervention, 16 hours after the intervention, 24 hours after the intervention
To assess the VAS value in order to measure the time elapsed from the intervention until reaching the appropriate level of analgesic efficacy. Analgesic efficacy is defined as the patient having a pain VAS value ≤ 3.
次要结局
- Complications(through study completion, an average of 30 days)