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临床试验/NCT01308554
NCT01308554已完成4 期

Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.

Funch-Jensen, Peter, M.D., D.M.Sc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
24h morphine consumption

研究概览

简要总结

The purpose of this study is to determine whether injection of bupivacaine into the TAP is effective in the treatment of post operative pain after laparoscopic gastric bypass

详细描述

Obesity surgery is expensive, although highly competitive to the cost of obesity related disease. An important step would be to reorganize obesity surgery into a day surgical procedure. Some reports already exist in the literature but the number of publications are sparse, and the description of the condition of the patient is limited. Our primary aim, therefore, is to investigate the influence transverses abdominis plane block has on pain after laparoscopic gastric bypass.

The benefits of adequate postoperative analgesia are clear, and include a reduction in the postoperative stress response, reduction in postoperative morbidity and in certain types of surgery, improved surgical outcome. The benefits of utilizing regional analgesic techniques compared to systemic analgesics include reduction in pain intensity, decreased incidence of side effects from systemic analgesics and improved patient comfort. Effective pain control thereby accelerates recovery from surgery.

A substantial component of the pain experienced by patients after abdominal surgery is derived from the abdominal wall incision.

The Transversus Abdominis Plane (TAP) Block was first described in 2001 in a letter by Dr. Rafi. McDonnell et al have developed and tested the block and describes it as a landmark technique. TAP Block involves blocking the sensory afferent nerves that supply the anterior abdominal wall including the skin, muscles and the parietal peritoneum. Hebbard et al subsequently described an ultrasound guided technique for the TAP block which they named the Posterior TAP block. The posterior TAP block provides analgesia on the lower abdominal wall. Hebbard also described another ultrasound-guided technique called the Oblique Sub costal TAP block which provides analgesia for surgery on the upper abdominal wall.

There is some debate over the extent of sensory blockade achieved by TAP block. Nerves supplying the anterior abdominal wall are derived from T16 to L1 and pass through this plane before supplying the anterior abdominal wall. Earlier studies showed a T7-L1 spread of the block after a single posterior TAP injection, while some newer studies revealed that the block failed to spread above T10 so was suitable only for lower abdominal procedures. In contrast the oblique sub costal TAP block can provide an effective analgesia after surgery that involves dermatome T6 to T10, in other word provide analgesia for surgery on the upper abdominal wall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged over 18 years who are scheduled for elective gastric bypass (incisions with the lower end of the incision at or above thoracic T 10 dermatome)

排除标准

  • Lack of consent including from those patients who lack mental capacity to give informed consent
  • Patients with history of drug allergy to bupivacaine
  • Patients with history of chronic pain conditions: defined as patients with history of pain for above 3 months and who consume regular analgesics for their chronic pain
  • American Society of Anesthesiologists (ASA) Class 4 and 5

研究组 & 干预措施

Marcaine

Active Comparator

Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.

干预措施: Marcaine (Drug)

结局指标

主要结局

24h morphine consumption

时间窗: 24h after the block is given

次要结局

  • The Verbal Analogue Scale (VAS) scores at rest and on moving(Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.)
  • Measurement of lung function (FEV1 and FVC)(Before surgery and 24h after.)
  • Post operative nausea score(Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.)

研究者

发起方
Funch-Jensen, Peter, M.D., D.M.Sc.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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