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临床试验/NCT05524038
NCT05524038已完成不适用

Comparison Between the Analgesic Effects of Ultrasound-guided Unilateral Quadratus Lumborum Block (Lateral Approach) Versus Erector Spinae Plane Block in Patients Undergoing Unilateral Lower Abdominal Surgery

Fayoum University Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
morphine consumption

研究概览

简要总结

the purpose of study is comparison between the analgesic effect of two techniques in adult lower abdominal surgeries

详细描述

the study will be performed from November 2021 to January 2023 at Fayoum University hospital after approval of the local institutional ethics committee and local institutional review board .A detailed informed consent will be signed by the eligible participants before recruitment and randomization.

Preoperative preparations and Premedication :•

Both groups will be assessed by history taking, careful examination ,and laboratory investigations like:

Complete blood count (CBC), coagulation profile:(prothrombin concentration(PC),Partial thromboplastin time(PTT),International Normalized Ratio(INR) ) , kidney function, liver function, ECG for patient >40 years old or indicated cases, specific investigations to each disease

.•the investigators will teach the patients Visual Analogue Score (VAS) and train them.

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, Care Provider)

盲法说明

Randomization will be done by random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened on the day of surgery when the patient is in the operating room and participant will receive either (QLB) or (ESPB) as per the envelope.

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

  • Patients age 18-60 years old.
  • Patients scheduled for elective abdominal surgeries
  • ASA classification I, II.
  • Ability to sign the consent.

排除标准

  • Patient refusal.
  • Coagulation disorders.
  • Skin lesions or infection at site of proposed needle.
  • Known allergy to local anesthetics, or opioids.
  • Patients suffering from neurological or mental disease.
  • Opioid consumption 48 hours before the operation.
  • Sever Obesity body mass index(BMI) >35
  • Difficulty in Ultrasonographic identification.

研究组 & 干预措施

(QL) group

Active Comparator

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Bupivacaine Hydrochloride (Drug)

(QL) group

Active Comparator

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Ultrasound device (Device)

(QL) group

Active Comparator

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Dexamethasone (Drug)

(QL) group

Active Comparator

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: echogenic needle (Device)

(ESB) group

Active Comparator

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Bupivacaine Hydrochloride (Drug)

(ESB) group

Active Comparator

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Ultrasound device (Device)

(ESB) group

Active Comparator

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: Dexamethasone (Drug)

(ESB) group

Active Comparator

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

干预措施: echogenic needle (Device)

结局指标

主要结局

morphine consumption

时间窗: 24 hours after the end of operation

Millie gram

次要结局

  • Pruritus(24hours after operation)
  • Ease of performance.(during performance of the block)
  • vomiting(24hours after operation)
  • patient satisfaction(24 hours after operation)
  • Bowel injury(24hours after operation)
  • intra vascular injection(24hours after operation)
  • Hematoma formation(24hours after operation)
  • Nausea(24hours after operation)

研究者

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

Rana Ahmed Abdelghaffar

lecturer of anesthesiology

Fayoum University Hospital

研究点 (2)

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