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临床试验/NCT02767544
NCT02767544Unknown不适用

Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial

Helsinki University Central Hospital0 个研究点目标入组 81 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
81
主要终点
Postoperative pain scores

研究概览

简要总结

In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain and need of oxycodone.

详细描述

Women assigned to laparoscopic hysterectomy were randomly divided into two groups as regard surgery: a ropivacaine group (RG) (n=41) and a control group (CG) (n=40). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours.

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
Single (Participant)

入排标准

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

入选标准

  • The criteria for inclusion were scheduled laparoscopic hysterectomy

排除标准

  • The exclusion Criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak Finnish or Swedish)

结局指标

主要结局

Postoperative pain scores

时间窗: Change in 24 hours after surgery

Visual Analog Score (VAS) for pain. Physicians Global Assessment to measure quality of pain. 10-point VAS score for pain (0-10), 0 indicating no pain and 10 indicating unbearable pain at 1,3,6,12 and 24 h (hour) after surgery (Units on a Scale; 0-10).

次要结局

  • Complication(Up to one week)
  • Nausea(Change in 24 hours after surgery.)
  • Length of hospitalisation(Up to one week)
  • The use of analgesics for postoperative pain(Change in 24 hours after surgery)
  • Vomiting(Change in 24 hours after surgery.)

研究者

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

Päivi Päkarinen

MD PhD

Helsinki University Central Hospital

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