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临床试验/NCT03508544
NCT03508544已完成不适用

Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block in Hip and Proximal Femur Surgery, Randomised Controlled Study

Maltepe University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月9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
60
试验地点
2
主要终点
Pain

研究概览

简要总结

Multimodal analgesia is used to control postoperative pain in hip surgery. Quadratus lumborum block is an effective regional anesthesia technique for hip and proximal femur surgery. The erector spinae plane block applied to the lumbar region was also reported to provide effective analgesia in these surgeons. In this study, we aimed to determine and compare the effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative pain in hip and proximal femur surgeons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Hip joint and proxiaml femur surgery, ASA 1-2-3

排除标准

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

研究组 & 干预措施

Lumbar ESP block

Active Comparator

Ultrasound-guided lumbar Erector spinae plane (ESP) block performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

干预措施: Lumbar ESP block (Procedure)

Lumbar ESP block

Active Comparator

Ultrasound-guided lumbar Erector spinae plane (ESP) block performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

干预措施: Standard Pain Followup and Monitorization (Other)

QLB Block

Active Comparator

Ultrasound-guided transmuscular quadratus lumborum block (QLB) performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

干预措施: Standard Pain Followup and Monitorization (Other)

QLB Block

Active Comparator

Ultrasound-guided transmuscular quadratus lumborum block (QLB) performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

干预措施: QLB bLock (Procedure)

Control

Sham Comparator

Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

干预措施: Standard Pain Followup and Monitorization (Other)

结局指标

主要结局

Pain

时间窗: 24 hours

Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

次要结局

  • analgesic consumption(24 hours)

研究者

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

Asst. Prof. Serkan Tulgar, M.D.

Assistant Professor

Maltepe University

研究点 (2)

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