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临床试验/NCT05905510
NCT05905510招募中4 期

Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty

Tanta University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
75
试验地点
1
主要终点
Assessment of postoperative pain

研究概览

简要总结

Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.

详细描述

Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.

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
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 30-75 years from both sexes.
  • ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.

排除标准

  • Patients' refusal.
  • Patients who were unable to co-operate with researchers.
  • History of allergy to local anesthetics.
  • Local infection at the site of the block.
  • Patients with bleeding and coagulation disorders.
  • Patients with renal, hepatic, cardiac decompensation, or spine deformities.
  • Patients receiving opioids for chronic analgesic therapy
  • Body mass index > 35 kg/m2

研究组 & 干预措施

Control Group

Active Comparator

Patients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%).

干预措施: spinal anesthesia plane block (Drug)

Lumbar Erector spinae plane block (L-ESPB)

Active Comparator

Patients will receive spinal anesthesia and then ipsilateral lumbar erector spinae plane block (30 ml bupivacaine 0. 25%) at the level of the lumbar region in the operating room after the end of the surgery.

干预措施: Lumbar Erector spinae plane block (L-ESPB) (Drug)

Fascia iliaca compartment block (FICB)

Active Comparator

Patients will receive spinal anesthesia and then ipsilateral suprainguinal fascia iliaca compartment block (30 ml bupivacaine 0. 25%) in the operating room after the end of the surgery.

干预措施: Fascia iliaca compartment block (FICB) (Drug)

结局指标

主要结局

Assessment of postoperative pain

时间窗: UP to 24 hour postoperatively

Assessment of postoperative pain using the Numeric rating scale (NRS), NRS is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain)

次要结局

  • Time required for the first rescue analgesia.(Up to 24 hours postoperatively)
  • The total postoperative rescue analgesic(first 24 hours postoperatively)
  • Adverse effects(Up to 24 hours postoperatively)

研究者

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

Ahmed Ahmed Zahran

Doctor Ahmed Ahmed Eldemrdash Zahran Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine,Tanta University

Tanta University

研究点 (1)

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