Transversus Abdominis Bilateral Plane Block in Total Laparoscopic Hysterectomy : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The ambulatory management after laparoscopic hysterectomy is a reality in our service, where 90% of hysterectomies are laparoscopically done and 80% of these are managed on an ambulatory basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79) range from 5 to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours)
So far the immediate analgesic management has been made systemically, and the satisfaction reported by patients was high, even though some patients require longer stay in recovery and need higher doses of analgesics before their discharge criteria, allowing an optimal ambulatory management.
There are several treatment options that theoretically could be used but the results have been variable and have failed to demonstrate the expected benefit.
The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the plane between the internal oblique and transverse abdominal, looking to infiltrate the spinal nerves at this level, so the innervation to the skin, muscles and the parietal peritoneum will be interrupted. The TAP Block was first described in 2001 , based on anatomy marks techniques of the peripheral nerves and was developed and evaluated later by McDonnell et al.
详细描述
The blockage in the abdominal transverse plane (TAP Block) with local anesthetic has demonstrated efficacy and safety in patients with various types of abdominal surgery by laparotomy as both laparoscopically.
The blockage in the abdominal transverse plane is a single entry in the triangle of Petit, to access a greater number of nerves that allow a wider spread of analgesia. The innervation of the anterolateral abdominal wall is given by the anterior branches of spinal nerves T7 to L1 (these include the intercostal nerves T7 at 11, the nerve subcostal nerve T12 and ilio hypogastric and ilio inguinal L1
The anterior divisions of the nerves T7 to T11 continues from the intercostal space and enter the abdominal wall between the internal oblique and transversus abdominis, reaching the rectus abdominis, which pierce and innervate the skin of the anterior abdominal region. In its course also innervate the external oblique muscle via the lateral cutaneous branch is divided into anterior and posterior innervating the external oblique and dorsal latium
The anterior branch of T12 is connected to the ilio hypogastric nerve and gives branch to the piriformis muscle, the lateral cutaneous branch pierces the internal and external oblique muscles and descends over the iliac crest innervate the anterior part of the buttocks.
The ilio hypogastric nerve,L1, is divided between the internal oblique and transversus abdominis near the iliac crest in two anterior and lateral cutaneous branches, the first innervate the skin of the buttocks and the second the hypogastric region.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for laparoscopic hysterectomy for benign causes.
- •ASA 1 and 2
- •Patients without contraindications to the administration of local anesthetics
- •Patients without contraindications to NSAIDs or acetaminophen.
- •Patients with no simultaneous intervention (only laparoscopic hysterectomy)
- •Patients living in the metropolitan area, with telephone line, can be contacted by telephone in the first 72 hours by calling 24, 48 and 72 hours, conducted by researchers at the number previously reported by the patient.
- •An adequate level of understanding, ie patients who are able to communicate by telephone and understand a numerical scale.
- •Who agree to participate in the work.
排除标准
- •Patients who should undergo a change in the standard anesthetic technique.
- •Patients who are hospitalized after total laparoscopic hysterectomy.
- •Patients with a body mass index above
- •Laparoscopic hysterectomy with a longer duration to 120 minutes.
- •Patients who do not they can be reached by phone at pre-set times.
研究组 & 干预措施
Bupivacaina
20 cc of bupivacaine 0.5% in 20 cc de saline solution and it is infiltrated 20 cc each side.
干预措施: Bupivacaina 0.5% (Drug)
saline solution
20 cc of saline solution 0.9% to infiltrate each side.
干预措施: placebo comparator (Drug)
结局指标
主要结局
Pain
时间窗: 24 hours
The instrument used to assess pain intensity is a straight line marked with numbers 1 to 10, with 1 meaning absence of pain and 10 the worst pain imaginable. The patient marks a point on the line that matches the pain she feels.
次要结局
未报告次要终点
研究者
Gustavo Adolfo Calle Gomez
Principal investigator
CES University