Comparative study of duloxetine and pregabalin on postoperative analgesic requirement following laparoscopic gynecological surgeries: A prospective, randomized, double blind and placebo-controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fentanyl requirements
研究概览
简要总结
Postoperative pain control is one of the main issues that plays a crucial role in hastening patients’ general condition improvement. Laparoscopic surgeries have many advantages over open surgery, such as smaller incisions, lower morbidity, rapid recovery, and reduction in hospital stays. However, a significant number of patients after laparoscopic surgeries still suffer from high levels of pain and require pain relief, with PONV being the second most common complaint. Duloxetine is a selective antidepressant that inhibits serotonin and noradrenaline reuptake in the central nervous system. Pregabalin is a structural analog of GABA and is an anticonvulsant drug that selectively affects pain transmission. Both drugs reduce acute pain and postoperative opioid consumption following some surgeries. Hence, the present study will be carried out to compare the postoperative analgesic efficacy of duloxetine and pregabalin in laparoscopic surgery. All selected patients will be randomized into 3 study groups (30 patients in each group)
Group D - Patients will receive duloxetine 60 mg, 2 hours before surgery
Group P - Patients will receive pregabalin 150 mg, 2 hours before surgery
Group C - Patients will receive similar-looking placebo 2 hours before surgery
Primary outcome - Total fentanyl requirements within 24 hours after surgery
Secondary outcome - VAS score at rest and on movement, adverse effects of study drugs (nausea, vomiting, dry mouth, urinary retention, ileus, urticaria, hypotension, bradycardia, respiratory depression, itching), sedation score, and patient satisfaction score.
Statistical analysis will be done after the completion of study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA grade I and II
- •Scheduled for laparoscopic gynecological surgery under general anesthesia.
排除标准
- •Known allergy to study drugs
- •History of PONV
- •Use of antiemetic drug within 24 hour of surgery
- •Morbid obesity (BMI.40)
- •Patient with history of hepatic, renal and cardiovascular dysfunction.
结局指标
主要结局
Fentanyl requirements
时间窗: Within 24 hours after surgery
次要结局
- VAS score at rest and on movement, adverse effects of study drugs (headache, nausea, vomiting, dry mouth, urinary retention, ileus, urticaria, hypotension, bradycardia, respiratory depression, itching), sedation score and patient satisfaction score.
