EUCTR2013-004124-11-GB进行中（未招募）1 期
Double blind randomised multicentre study to assess the effect of local anaesthesia during vaginal hysterectomy - Effect of local anaesthesia during vaginal hystectomy on post-op pain
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
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
- •1. Female patient aged 18 years
- •2. Patients who will be undergoing vaginal hysterectomy
- •3. Capable of written informed consent in English
- •4. Patient is willing and able to complete pain scale questionnaire correctly
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 206
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients undergoing any other concomitant procedure including and not limited to:
- •-Any abdominal incisions e.g. laparoscopy/laparotomy;
- •-Simultaneous mid-urethral tape insertion;
- •-Concomitant sacrospinous ligament fixation
- •(Vaginally applied uterosacral plication and McCall’s culdoplasty can be considered routine steps of a vaginal hysterectomy and are not reasons to exclude. Simultaneous pelvic floor repair is also not a reason to exclude);
- •2. Any patient who will receive a regional block e.g. Epidural, spine or TAP block
- •3. Patients with previous pelvic irradiation;
- •4. Patients with a history of previous pelvic floor surgery;
- •5. Patients who are allergic to analgesia on the international standardised post-operative analgesic prescription;
- •6. Patients using patient-controlled analgesia;
- •7. Patients who are allergic to local anaesthesia/adrenaline;
- •8. Patients who are already taking regular analgesia for chronic pain e.g. back or hip pain;
- •9. Patients taking anti-coagulation pre-operatively which would be highly active during the operation e.g. Aspirin/Clopidogrel five days prior to the operation date or Low-Molecular-Weight Heparin on day of the operation;
- •10. Patients treated with class III anti-arrhythmic drugs (e.g. Amiodarone);
- •11. Patients with partial or complete heart block – due to the fact that local anaesthetics may depress myocardial conduction;
- •12. Patients with advanced liver disease or severe renal dysfunction;
- •13. Any patient deemed unsafe for local anaesthetic by the anaesthetist;
- •14. Any patient who will receive Halogenate general anaesthesia for this pelvic floor surgery; and
- •15. Any patient who is pregnant; every patient who has consented for an elective hysterectomy will not be pregnant.
研究者
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