Preemptive Analgesia With Amitryptyline for Prevention of Post-operative Pain in Women After Total Abdominal Hysterectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twenty-four hours after surgery
研究概览
简要总结
The purpose of this study is to determine whether amitryptyline is effective in the prevention of pain in women after a total abdominal hysterectomy.
详细描述
It will be performed a randomized clinical trial, double-blind, placebo-controlled, with two branches: one group receiving preemptive analgesia with amitryptyline and one receiving placebo. Blind procedures (blinding):
- The participant does not know which group participates;
- The evaluator does not know to which group it belongs to every individual;
- The tablets provided to patients will be identical.
Study population All patients with total abdominal hysterectomy indication attended in Gynecological Surgery clinic of the Hospital Pedro I.
Sample
It will be obtained a non-consecutive probability sample offering to participate in the study to all women that is going to be submitted to total abdominal hysterectomy indication in the referral hospital from june 2015 to june 2016. Then these will be submitted to randomization process as explained later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for total abdominal hysterectomy for benign conditions (e.g. hemorrhagic and / or uterine fibroid disorder);
- •Age between 18 and 60;
排除标准
- •Endometriosis;
- •Abnormal cervicovaginal smears;
- •Uterine prolapse;
- •Patients with a history of intolerance to opioids or narcotics;
- •Patients with contraindications to the use of amitriptyline (e.g., ischemic heart disease, glaucoma)
- •addicted to alcohol or drugs;
- •Use of analgesics in the 24 hours prior to the possible administration of amitriptyline;
- •Failure to provide informed consent;
- •Different anesthesia from spinal anesthesia
研究组 & 干预措施
Amitryptyline
Patients who will be take amitryptyline, 75mg, only use, 30min before surgery.
干预措施: Amitriptyline (Drug)
Placebo
Patients who will be take placebo 30min before surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twenty-four hours after surgery
时间窗: Twenty-four hours after surgery
The postoperative pain will be measured twenty-four hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain)
次要结局
- Intensity of acute postoperative pain twelve hours after the procedure(Twelve hours after the procedure)
- Intensity of acute postoperative pain twenty-four hours after the procedure(Twenty-four hours after the procedure)
- Records of rescue analgesia(From the end of the procedure until 48 hours after that)
- Frequency of adverse effects(From the end of the procedure until 48 hours after that)
- Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, forty-eight hours after surgery(Forty-eight hours after surgery)
- Intensity of acute postoperative pain forty-eight hours after the procedure(forty-eight hours after the procedure)
- Length of hospitalization(participants will be followed for the duration of hospital saty, an expected average of 48 hours.)
- Intensity of acute postoperative pain six hours after the procedure(Six hours after the procedure)
- Compare surgical time (duration, in minutes) and frequency of intraoperative and postoperative complications(From the end of the procedure until sixty days after that.)
- Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, six hours after surgery(Six hours after surgery.)
- Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twelve hours after surgery(Twelve hours after surgery)
研究者
Antonio Henriques de França Neto
Principal Investigator
University of Campinas, Brazil