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临床试验/NCT03421821
NCT03421821已完成不适用

Extrafascial Injection Versus Subfascial Injection of Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Changes of pain intensity of the 3 holes at 48 hours post-operation

研究概览

简要总结

Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatome can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatome were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior layer of thoracolumbar extrafascial, this produced the dermatomal coverage from lower abdominal to hip. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascia, the lower thoracic dermatome were blocked.

详细描述

Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatomes can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatomes were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior thoracolumbar extrafascial (between the anterior layer of thoracolumbar fascia and psoas major muscle), this produced the dermatomal coverage from lower abdominal to hip. In this case, the investigators speculated the local anesthetic spread to the lumbar paravertebral space via the fascia and the fascicle of psoas major. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascial (between the anterior layer of thoracolumbar fascia and quadratus lumborum), the lower thoracic dermatomes were blocked. The investigators speculate that the local anesthetic injected subfascial could spread cephalad to lower thoracic paravertebral space posterior to the endothoracic fascia via lateral arcuate ligament.

The investigators confirm the hypothesis in the pilot trial. therefore, the investigators need to trial with large sample. The investigators plan to improve the clinical guidance of quadratus lumborum block technology, so that more patients benefit.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants undergoing laparoscopic cholecystectomy. ASA: I~II. BMI: 17~
  • The operation time is less than 2 hours. Participants volunteered for the trial.

排除标准

  • Pregnant and lactation women. Coagulation disorders. Drug allergy. Can not communicate normally. Bacteremia. Emergency surgery. ASA: >III.

研究组 & 干预措施

Subfascial Injection Group

Experimental

30 ml of 0.33% ropivacaine was injected to subfascial.

干预措施: Ropivacaine (Drug)

Extrafascial Injection Group

Active Comparator

30 ml of 0.33% ropivacaine was injected to extrafascial.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Changes of pain intensity of the 3 holes at 48 hours post-operation

时间窗: 48 hours after operation

The three holes include the Subxiphoid hole, Subcostal hole and supraumbilical hole in the laparoscopic cholecystectomy. Patients reported pain intensity of each hole in the post-operation of 1 hour, 6 hours, 12 hours, 24 hours, 36 hours and 48 hours. Each item is scored 0-10 (0 = no pain; 10= pain as bad as can be).

次要结局

  • patients satisfaction(48 hours after operation)
  • Adverse effects(48 hours after operation)
  • Postoperative analgesic consumption(48 hours after operation)
  • dependent ambulation(at 1 and 6 hours after surgery)
  • Sensory block level(30 min after blocked)
  • Limbs weakness(at 30 min after block)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenquan He

Attending physician of anesthesiology department

Third Military Medical University

研究点 (1)

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