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临床试验/NCT00918437
NCT00918437已完成不适用

Characterization of the Postoperative Pain Course and Intensity After Uvulopalatoplasty With Radiofrequency Knife (RAUP)

Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Pain Intensity 0-10 Numerical Rating Scale

研究概览

简要总结

The aim of this study is to determine the postoperative course including effects on the quality of life following soft palate surgery with radiofrequency knife (RAUP).

详细描述

For the treatment of social snoring one common treatment modality is the surgical reconstruction of the soft palate. The procedure is a routine operation performed at nearly all Ear-Nose- and Throat departments in Norway. The surgery is done with local anaesthesia in an out-patient setting where the patients' postoperative observation at the hospital is limited to 1-2 hours. As the surgery is done in the sensitive mucosa and palatopharyngeal musculature the postoperative course might be unpleasant. The patients are therefore in the need of regular postoperative pain treatment extending into the 2 first weeks after surgery.

At hospitals the uvulopalatoplasty is performed using a radiofrequency knife (RAUP) after the soft palate has been infiltrated with local anaesthesia (1% xylocain/adrenaline). The incision is done paramedialy to the uvular base and up into the musculature of the soft palate then making a smooth arch toward the pharyngeal tonsil upper limit. The then elongated uvula is amputated to about ½ cm. Occasionally, a suture is placed laterally and medially to lift the palate and prevent postoperative scaring. Coagulation is done if necessary with light bipolar diathermy.

As the postoperative course might be unpleasant after RAUP it is of interest to study the time course and intensity of pain after surgery when using the standardised postoperative pain treatment at OmniaSykehuset. The result will be useful in future studies looking at ways to improve the pain treatment after uvulopalatoplasty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either sex of Caucasian origin who are referred to the hospital for snoring that have been subjected to a sleep study indicating that uvulopalatoplasty might have a considerable affect on the snoring.

排除标准

  • Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
  • Patients with diabetes.
  • Patients who due to age or communication skills are considered unable to complete patient forms.
  • Professional evaluation suggests an alteration of the planned surgical area or treatment form.
  • Known or assumed intolerance or hyper sensibility to diclofenac, codeine or paracetamol (standard postoperative analgesic treatment).
  • Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7

结局指标

主要结局

Pain Intensity 0-10 Numerical Rating Scale

时间窗: 14 days

次要结局

  • Norwegian McGill Pain Questionnaire (NMPQ)(14)
  • Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)(14 days)
  • Oral Health Impact Profile (OHIP-14)(14 days)
  • Corahs Dental Anxiety Scale (CDAS)(1 day)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (1)

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