跳至主要内容
临床试验/NCT01157546
NCT01157546终止1 期

Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
终止
发起方
入组人数
25
试验地点
2
主要终点
Postoperative morphine consumption

研究概览

简要总结

This is a prospective, double blind, randomized study is proposed in patients undergoing open radical prostatectomy: its objective is to establish whether continuous bilateral TAP blocks would provide adequate perioperative analgesia, decrease opioid consumption, reduce the incidence of opioid-related side effects, and facilitate surgical recovery (in terms of PACU and hospital discharge).

详细描述

Open prostatectomy is a surgical procedure performed by urologists to excise the prostate. This is achieved by a 10-cm vertical incision starting below the umbilicus and reaching the pubic area. Patients are hospitalized for 3-4 days: one of the criteria for safe discharge includes Visual Analogue Scale (VAS) for pain below 3 at rest. For postoperative pain control, patients receive patient-controlled opioid analgesia (PCA) with morphine. The average amount of morphine used in the first 24 h varies between 30 and 50 mg. Although this technique is widely used, side effects (sedation, ileus, pruritus) are commonly encountered with opioid administration. Thus alternative analgesic techniques such as epidural analgesia and wound infiltration have been used with some success. However adverse events have also been reported with these techniques (lower limb motor block with epidural; infection wound infiltration).

In the last 10 years, a new technique, the transversus abdominis plane (TAP) block, which anesthetizes the thoracolumbar nerves (intercostal, subcostal and first lumbar nerves), has been described. The thoracolumbar nerves provide sensory innervation to the anterolateral abdominal wall. The traditional technique for TAP blocks is performed with a blunt needle in the Triangle of Petit. The latter is delineated caudally by the iliac crest, posteriorly by the latissimus muscle and anteriorly by the external oblique. Two distinct pops can be felt as the needle crosses the fascial extensions of the external oblique and the internal oblique muscle, respectively. Thus the second pop usually signifies that the needle tip has reached the TAP. Although the traditional technique has been used to provide postoperatively analgesia for bowel surgery, hysterectomy and Cesarian Section, the position of the Triangle of Petit varies greatly thus making it difficult to palpate in obese patients. In 2007, there was a study describing an ultrasound-guided technique for TAP blocks: these authors advocated using ultrasonography to locate the TAP along the mid-axillary line above the iliac crest. This ultrasound-guided technique has been subsequently used to provide postoperative analgesia for laparoscopic cholecystectomy, appendicectomy and Cesarian Section. This technique has been shown to spare opioids in the postoperative period therefore facilitating an accelerated discharge and superior pain relief.

In our institution, the TAP block, either as a single shot or as a continuous catheter infusion, is used for abdominal and urological surgery when epidural blockade is not feasible.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 18 years and over
  • ASA class 1, 2
  • Elective open radical prostatectomy

排除标准

  • Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range
  • Any chronic use of opioid analgesic
  • Morbid obesity (BMI>40)
  • History of allergic reactions to any of the study medications and the medications used for the trial
  • Pregnancy
  • Previous abdominal surgery

结局指标

主要结局

Postoperative morphine consumption

时间窗: at 24 hour after surgery

次要结局

  • Incidence of nausea and vomiting(at 2, 12, 24 and 48 hour after surgery)
  • VRS for pain at rest, during ambulation and coughing(at 2, 12, 24 and 48 hour after surgery)
  • Assessment of recovery(at 24 hours after the surgery and every 24 hours until patients are discharged.)
  • Postoperative morphine consumption(at 2, 12 and 48 hours after surgery)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Baldini, MD, MSc, Assistant Professor

MD, Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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