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临床试验/NCT02642796
NCT02642796已完成不适用

Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery

Mustafa Kemal University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Visual analog scale for pain

研究概览

简要总结

Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.

详细描述

The patients underwent undergo fractured hip surgery will be distributed into three groups with respect to the mode of postoperative analgesia applied: Group I (control): PCA only; group II: PCA plus lumbar plexus & sciatic nerve TENS (LS-TENS); group III: PCA plus surgical wound TENS (SW-TENS). TENS will be applied every 2 hours for 30-40 minutes during 48 hours postoperatively. Visual analogue score (VAS), Ramsey sedation scores, frequencies of PCA demand and counts of PCA delivery, as well as total analgesic consumption will be noted and compared between groups at various time intervals.

Visual analog scale (VAS) will be applied at 2 months postoperatively VAS and Mcgill pain questionnaire will be applied at the 6th and 24th months of the surgery to assess acute and chronic pain in the study population and the differences among groups.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Adult patients will be scheduled for surgery due to hip fracture in Mustafa Kemal University Hospital will be included in the study.

排除标准

  • Patients with a history of opioid analgesic abuse, or sensitivity to opioids, and those with clinically significant systemic (cardiovascular, pulmonary, hepatic, renal, neurologic etc.) diseases, will be excluded.

结局指标

主要结局

Visual analog scale for pain

时间窗: 48 h postoperatively

Postoperative pain intensity is assessed using VAS for pain postoperatively.

次要结局

  • Frequencies of PCA demand(48 h postoperatively)
  • Ramsey sedation scores(48 h postoperatively)
  • Total fentanyl consumption(48 h postoperatively)
  • PCA delivery counts(48 h postoperatively)

研究者

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

MENEKSE OKSAR

Assistant Professor

Mustafa Kemal University

研究点 (2)

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