The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Acute pain after cough
研究概览
简要总结
An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in neuropathic pain with promising results. A considerable number of patients undergoing surgery under general anesthesia are hypertensive and receive drugs to control high blood pressure, including angiotensin II receptor antagonists. These drugs may attenuate the acute and/or chronic postoperative pain or decrease the analgesic requirements after surgery. The aim of the present study is to assess the early postoperative pain and analgesic requirements in patients treated with antagonists of the angiotensin II receptors for at least three months before surgery compared to normotensive patients.
详细描述
Patients ASA I-III, aged between 35 and 79 years old, with BMI ≤ 35, scheduled for abdominal surgery, thus gynecological, urological and general surgery procedures will be recruited for the study. All patients will be scheduled in the morning list, informed for the study and will be asked to give written informed consent.
Exclusion Criteria will be patients on analgesic, antidepressive, or sedative consumption during the previous one month, mental impairment, not speaking Greek or refusing to give written informed consent, diabetics, patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists.
Two groups of patients will be stydied: Patients hypertensive (the hypertensive group) receiving treatment for blood pressure control with angiotensin II receptor antagonists for at least three months preoperatively and a normotensive group.
Measurements
- Pain intensity (visual analogue scale: VAS) from 0 to 100 will be reported 2, 4, 8, and 24 hours postoperatively with 0 representing no pain and 100 excruciate worst pain. Pain will be recorded at rest and subsequently patients will be asked to cough for three times.
- Analgesics consumed at the same time points will be recorded.
- Patient satisfaction (VAS 0-100) 24 h postoperatively (with special reference to pain)
- Three months postoperatively patients will be contacted by phone and will be asked if they experience pain related to surgery or not. If yes pain characteristics, thus burning, pricking etc. will be recorded.
- Three months postoperatively patients will be asked whether they used analgesics after discharge from the hospital for the postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 35 and 79 years
- •ASA II or III
- •Elective abdominal surgery
排除标准
- •Patients on analgesic, antidepressive, or sedative consumption during the last month
- •Mental impairment
- •Not speaking fluently Greek language
- •Refuse to give written informed consent
- •Diabetics
- •Patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists
研究组 & 干预措施
angiotensin type II receptor antagonists
Hypertensive patients treated with angiotensin type II receptor antagonists
干预措施: Angiotensin type II receptor antagonists (Drug)
结局指标
主要结局
Acute pain after cough
时间窗: 24 hours postoperatively
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
次要结局
- Acute pain at rest(2, 4, 8 and 24 hours postoperatively)
- Acute pain after cough(2, 4 and 8 hours postoperatively)
- Analgesic consumption(2, 4, 8 and 24 hours postoperatively)
- Chronic pain(Three months postoperatively)
- Analgesic consumption for chronic pain(Three months postoperatively)
研究者
Argyro Fassoulaki
Professor Emeritus
University of Athens