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临床试验/NCT04705974
NCT04705974Unknown不适用

Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures

研究概览

简要总结

This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.

详细描述

Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 - 85 years
  • American Society of Anesthesiologists physical statusⅠ- Ⅲ
  • Patients will receive hip replacement

排除标准

  • Patient refusal
  • Cognitive impairment(NRS pain score cannot be assessed)
  • Peripheral neuropathy
  • Mutiple furacture
  • skin infection at the site of injection
  • allergy to ropivacaine、lidocaine or bupivacaine
  • contraindication to spinal anesthesia

结局指标

主要结局

The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures

时间窗: up to 24 months

The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.

次要结局

未报告次要终点

研究者

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

Wei Mei

Professor

Huazhong University of Science and Technology

研究点 (1)

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