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临床试验/IRCT20200502047263N1
IRCT20200502047263N1已完成3 期

Study of Pregabalin Effect on Post Surgical Pain on Breast Cancer Patients Underwent Axillary Dissection: a Double Blind Randomized Clinical Trial Using Placebo

Tehran University of Medical Sciences0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
250

研究概览

简要总结

Abstract Objective: To investigate post op pain after breast cancer surgery. Summary background data: Breast cancer is the most prevalent cancer among women. Current treatments made 5 year survival more than 90%. Thus there is a lot of focus on reducing morbidities due to the treatments. Post surgical pain is a common complaint, affecting 60% of patient who underwent breast cancer surgery. Through literature there are promising evidences that pregabalin can reduce post mastectomy pain. To prove this theory more data is needed. Methods: This is a randomized double blinded clinical trial controlled with placebo. Total number of 166 patients was randomly assigned in two groups. Pregabalin group received 75mg pregabalin 1h before surgery followed by 75mg every 12h for 15 days. Control group received placebo equivalent for the same period. We used Verbal Numerical rating scale to evaluate patients’ pain at 24h, 48h, 1W, 1M and 6M after surgery. Results: Mean pain scores in both rest and arm abduction were significantly less in pregabalin group in 24h, 48h and 1W after surgery. There was no difference in 1 month and 6 month. Morphine usage was lower in pregabalin group. Adverse side effects such as nausea, headache, dizziness and blurred vision were not different between two groups. Conclusions: Perioperative use of pregabalin in breast cancer surgery is safe. It can reduce acute post op pain and morphine consumption. This study failed to show any long term effect on chronic pain.

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 no limit(—)
性别
Female

入选标准

  • Patients who underwent breast cancer surgery at Shariati hospital and Imam khomeini Cancer institute in 2019

排除标准

  • Patient denial to participate in the study
  • Known cases with sensitivity to pregabalin
  • History of seizure
  • Patients who were already using Pregabalin or gabapentin or opioids
  • Patients who were unable to cooperate with data gathering, physically or emotionally
  • GFR less than 60

研究者

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