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临床试验/NCT03323684
NCT03323684已完成不适用

Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

Mansoura University2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2017年10月1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
159
试验地点
2
主要终点
Cumulative postoperative fentanyl consumption (total dose given in micrograms)

研究概览

简要总结

In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.

详细描述

The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.

The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Physical Status I or II

排除标准

  • Patient refusal.
  • Hematological diseases
  • bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Emergency laparoscopic cholecystectomy
  • if laparoscopic procedure converted to open.

研究组 & 干预措施

Quadratus lumborum block Group (QL)

Experimental

Quadratus lumborum block will be performed

干预措施: Quadratus lumborum block Group (QL) (Other)

Quadratus lumborum block Group (QL)

Experimental

Quadratus lumborum block will be performed

干预措施: Paracetamol infusion (Drug)

Quadratus lumborum block Group (QL)

Experimental

Quadratus lumborum block will be performed

干预措施: Ketorolac analgesia (Drug)

Quadratus lumborum block Group (QL)

Experimental

Quadratus lumborum block will be performed

干预措施: fentanyl (Drug)

Transversus abdominis plane Group (TAP)

Experimental

Subcostal transversus abdominis plane will be performed

干预措施: Transversus abdominis plane Group (TAP) (Other)

Transversus abdominis plane Group (TAP)

Experimental

Subcostal transversus abdominis plane will be performed

干预措施: Paracetamol infusion (Drug)

Transversus abdominis plane Group (TAP)

Experimental

Subcostal transversus abdominis plane will be performed

干预措施: Ketorolac analgesia (Drug)

Transversus abdominis plane Group (TAP)

Experimental

Subcostal transversus abdominis plane will be performed

干预措施: fentanyl (Drug)

Control group (C)

Experimental

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

干预措施: Control group (C) (Other)

Control group (C)

Experimental

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

干预措施: Paracetamol infusion (Drug)

Control group (C)

Experimental

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

干预措施: Ketorolac analgesia (Drug)

Control group (C)

Experimental

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

干预措施: fentanyl (Drug)

结局指标

主要结局

Cumulative postoperative fentanyl consumption (total dose given in micrograms)

时间窗: For 24 hours after surgery

次要结局

  • Mean arterial blood pressure (mmHg)(For 4 hours after start of anaesthesia)
  • Dermatomal distribution of the extent of the blockade will be assessed by pinprick method(the first one hour after surgery)
  • Postoperative pain severity will be assessed using VAS(For 24 hours after surgery)
  • Cumulative intraoperative fentanyl consumption (total dose given in micrograms)(For 4 hours after start of anaesthesia)
  • Heart rate(For 4 hours after start of anaesthesia)
  • Time for the first request to rescue analgesia (in minutes)(For 24 hours after surgery)
  • length of stay at PACU (in minutes)(For 24 hours after surgery)
  • Incidence of postoperative nausea and vomiting(For 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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