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临床试验/NCT04688814
NCT04688814已完成3 期

(SEQ Block): Single Puncture Combined Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block for Perioperative Analgesia in Acetabular Surgeries

Alexandria University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
52
试验地点
1
主要终点
Total postoperative morphine consumption

研究概览

简要总结

The study will evaluate ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block when compared with conventional intravenous morphine analgesia in patients undergoing posterior column acetabular fracture surgery

详细描述

Introduction: Acetabular fractures represent relatively infrequent traumatic injuries that can lead to a progressive impairment of hip articular function. Surgical treatment of these fractures may require extensive surgical dissections and frequently is associated with significant postoperative pain, delay in rehabilitation, and prolonged hospital stay. Innervation of the acetabular region is mainly provided by branches of lumbar and sacral plexuses, in addition to dorsal rami of lumbar nerve roots supplying the tissues to be dissected during posterior approach for acetabular fractures. Investigators suggest a novel approach for combined lumbar erector spinae plane block and PSSS quadratus lumborum block for perioperative analgesia in hip/acetabular surgeries using a single puncture technique (SEQ block).

Aim of the study: The primary aim of this study is to compare the total postoperative opioid (morphine) consumption after posterior column acetabular surgery when providing ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block versus conventional intravenous morphine analgesia.

The secondary aims of this study are; intraoperative and postoperative hemodynamics; Mean arterial blood pressure (MAP) and heart rate (HR), resting visual analogue scale (VAS), dynamic VAS and postoperative complications.

Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out starting from December 2020 for 1 year in Alexandria university hospital on 52 American Society of Anesthesiologists (ASA) physical status I-III patients scheduled for unilateral posterior wall/column acetabular fractures surgery using posterior approach. The exclusion criteria will include; Body mass index (BMI) > 35 kg/m2, pre-existing neurological deficit, spine deformity, pregnancy/lactation, significant renal or hepatic impairment, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers.

Patients will be divided randomly by closed envelope method into 2 groups. Group SEQ; patients will receive ultrasound guided SEQ block preoperatively before the induction of general anaesthesia (GA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

Double blinded

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-III patients
  • Unilateral posterior wall/column acetabular fractures surgery using posterior approach

排除标准

  • BMI > 35 kg/m2
  • Pre-existing neurological deficit
  • Spine deformity
  • Pregnancy/lactation
  • Significant renal impairment
  • Significant Hepatic impairment
  • Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection)
  • Chronic opioid users/abusers

研究组 & 干预措施

Morphine Group

Active Comparator

Patients will receive GA and analgesia will be based on opioids mainly intravenous morphine. Intravenous morphine in a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4 postoperatively for 24 hours

干预措施: Morphine Sulfate (Drug)

SEQ group

Experimental

Patients will receive ultrasound guided SEQ block preoperatively before the induction of general anaesthesia. Twenty five ml of 0.25 % bupivacaine will be given in the QL plane and 25 ml of the same concentration will be given in the erector spine plane

干预措施: Single puncture combined lumbar erector spinae plane block and quadrates lumborum block (Procedure)

结局指标

主要结局

Total postoperative morphine consumption

时间窗: 24 hours postoperatively

Compare the total postoperative opioid (morphine) consumption after posterior column acetabular surgery when providing ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block versus conventional intravenous morphine analgesia. Morphine 0.05 mg/kg will be given intravenously when VAS score is ≥ 4. The total postoperative morphine consumption in milligrams will be recorded.

次要结局

  • Heart rate (HR)(24 hours)
  • Mean arterial blood pressure (MABP)(24 hours)
  • Postoperative complications(24 hours)
  • Resting and dynamic visual analogue score(24 hours)

研究者

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

moustafa abdelaziz

Professor of Anaesthesia and Surgical Intensive Care

Alexandria University

研究点 (1)

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