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临床试验/NCT01007565
NCT01007565已完成2 期

Postoperative Pain After Volar Plating for Distal Radius Fractures

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
44
试验地点
2
主要终点
postoperative pain level

研究概览

简要总结

The investigators undertook to evaluate early postoperative pain levels after the volar plating of distal radius fractures performed under regional anesthesia, and to determine whether periarticular multimodal drug injections into the joint, ligament, periosteum, subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an additional sensory nerve block) provide additional pain management benefits.

详细描述

To evaluate whether periarticular injections (PI) had additional pain management benefits, patients were randomly allocated to two groups, that is, the PI and No-PI groups, using a randomization table. Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure. For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve.

A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve. The anterior interosseous nerve was blocked in the course of the pronator quadratus and posterior interosseous nerve in the 4th dorsal extensor compartment.

The mixture of anesthetics consisted of 2 ampules of ropivacaine HCl (Naropin®, 0.75%, 7.5mg/ml, 20ml/ⓐ), 1 ampule of morphine sulfate (5mg/ⓐ), 1 ampule of epinephrine HCL (1mg/ml, 1ml/ⓐ) and normal saline 20cc.

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

入排标准

年龄范围
16 Years 至 89 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • distal radius fracture with or without a styloid fracture not requiring surgery

排除标准

  • multiple trauma
  • a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation
  • regularly narcotics user
  • those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.

结局指标

主要结局

postoperative pain level

时间窗: 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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