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临床试验/NCT07448987
NCT07448987已完成不适用

Comparison of The Efficacy of Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation: Prospective Randomized Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This study aimed to compare the efficacy of ultrasound guided trans-muscular quadratus lumborum Block, thoracolumbar interfascial plane block and local anesthetic infiltration for elective lumbar spine fixation undergo up to three-level fixation.

详细描述

Back and leg pain arising from lumbar spine surgery is widespread, and its treatment can range from pharmacotherapy to surgical intervention. A majority of patients who undergo spinal surgery report experiencing moderate pain six months after the operation.

Interfascial plane blocks, including the thoracolumbar interfascial plane (TLIP) block target these posterior rami passing through the paraspinal muscles. Several studies have explored the analgesic efficacy of TLIP block in posterior lumbar spine surgery.

Quadratus lumborum block (QLB) is a posterior abdominal wall fascial block where local anesthetic is administered around QL muscle. play a significant role in contemporary medical practice for enhancing post-spinal surgery pain management.

Local infiltrative analgesia applied in layers of the surgical wound layers has been suggested as an appealing alternative due to its simplicity, enhanced safety, and limited cost, also a popular modality for postoperative analgesia in spine surgery.

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

入选标准

  • Age from 18 to 65 years.
  • Both genders.
  • American Society of Anesthesiology (ASA) class I - II.
  • Scheduled for elective lumbar spine fixation up to three level.

排除标准

  • Patient refusal.
  • History of allergy to local anesthetic.
  • Mental dysfunction or cognitive disorders.
  • Body Mass Index > 30 kg/m
  • Coagulopathy.
  • Pregnancy.
  • Infections to the site of the block.

研究组 & 干预措施

Group I: QLB group

Experimental

Patients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).

干预措施: Quadratus lumborum block (Other)

Group II: TLIP block group

Experimental

Patients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).

干预措施: Thoracolumbar interfascial plane block (Other)

Group III: Local wound infiltration group

Experimental

Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg).

干预措施: Local anesthetic infiltration (Other)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Intravenous morphine (0.05mg/kg) was given when numeric rating scale (NRS) equal or above 4.

次要结局

  • Mean arterial pressure(Till end of surgery (Up to 2 hours))
  • Heart rate(Till end of surgery (Up to 2 hours))
  • Time to the first request for rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)

研究者

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

Adel Fareed Elkot

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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