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临床试验/CTRI/2025/06/088525
CTRI/2025/06/088525尚未招募4 期

Comparative study of duloxetine and pregabalin on postoperative analgesic requirement following laparoscopic gynecological surgeries: A prospective, randomized, double blind and placebo-controlled trial

Apollo Hospitals Bilaspur1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年6月25日最近更新:

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.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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