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临床试验/NCT06721039
NCT06721039已完成不适用

Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block Versus Intraperitoneal and Periportal Bupivacaine Infiltration in Postoperative Analgesia After Laparoscopic Cholecystectomy

medina medical center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4月3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
发起方
入组人数
70
试验地点
1
主要终点
pain score postoperative

研究概览

简要总结

The primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.

详细描述

Since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. The proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications.

The most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.

Intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. This technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. But as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. The choice of anaesthetic block technique depends upon the site of surgical incision proposed.

Quadratus lumborum (QL) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia.

This interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (Kadam, 2013).

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
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 21-60 years of both sexes.
  • •Elective laparoscopic cholecystectomy under general anesthesia.
  • •Physical Status: ASA I and II patients after taking written and informed consent.

排除标准

  • •• Refusal of procedure or participation in the study by patients.
  • •Physical status: ASA III or above.
  • •Infection at site of injection.
  • •Psychiatric illness that leads to inability to cooperate, speak or read.
  • •Daily use of opioids.
  • •History or evidence of coagulopathy especially if INR>1.5 and platelet <100.000
  • •Allergies to drugs used (Bupivacaine 0.5%).

研究组 & 干预措施

Group 2

Active Comparator

Intraperitoneal and port sites infiltration with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes

干预措施: Intraperitoneal and port sites infiltration (Drug)

Group 1

Active Comparator

Bilateral QL block: sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes

干预措施: Bilateral QL block (Drug)

结局指标

主要结局

pain score postoperative

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
medina medical center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Gamal Salah Elsawy

lecturere of anaesthesia and intensive care

medina medical center

研究点 (1)

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