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临床试验/EUCTR2014-004236-19-SE
EUCTR2014-004236-19-SE进行中(未招募)1 期

Pudendal block after posterior vaginal surgery. A randomized controlled trial on postoperative pain.

andstinget i Östergötland0 个研究点目标入组 50 人开始时间: 2014年12月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Women between 18 and 70 years of age.
  • The patient is scheduled for primary posterior vaginal reconstructive surgery because of posterios vaginal wall prolapse or suboptimally healed tear from previous delivery injury including suture between muscle tendons in local anesthesia and sedation.
  • The woman can understand and express herself in Swedish.
  • The woman agrees to participate in the study after written and verbal information through the signature of the form informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 45
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • Additional surgery planned while at the hospital for the operation.
  • Hypersensitivity to Ropivacaine, to other local anesthetics of the amide type, or to
  • sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
  • Hypovolemia
  • The woman is disabled and can’t be expected to be mobilized the day after surgery in the same way as non-disabled people.
  • The woman is mentally incapacitated to such an extent that she can’t complete the relevant questionnaires, understand the implications of participating in the study, or the patient's participation it may be ethically questionable if
  • The woman has severe mental illness or medication for severe mental illness. The responsible doctor considers it inappropriate that patient will be included in the study.
  • Women with chronic pelvic pain
  • Woman taking medication for severe pain with drugs other than paracetamol and NSAIDs, which can affect the outcome measure.

研究者

发起方
andstinget i Östergötland

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