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IRCT20200502047263N1 IRCT 2020-05-08 Tehran University of Medical Sciences Study of Pregabalin effect on breast cancer surgery Study of Pregabalin Effect on Post Surgical Pain on Breast Cancer Patients Underwent Axillary Dissection: a Double Blind Randomized Clinical Trial Using Placebo 2019-04-21 anticipated 250 Complete https://irct.ir/trial/47605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: Simple, each Patient has equal odds to be placed in intervention group or control group Randomization unit: Each patient No randomization layers was used randomization tool: Random allocation software Randomization sequence was created by software after defining each group and sample size allocation concealment: central telephone randomization system, researcher telephone the pharmacotherapist and asks what group next patient will be, Blinding description: Patients, Researcher, Doctors and nurses and Data gatherers were blind towards the drug. Evaluator and analyzer were not blind. 3 Post op Pain after breast cancer surgery. Intervention 1: Intervention group: 75 mg Pregabalin 1h before surgery orally then every 12h until 15 days after surgery. Intervention 2: Control group: 75 mg Placebo 1h before surgery orally then every 12h until 15 days after surgery. https://onlinelibrary.wiley.com/doi/abs/10.1111/tbj.13979 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. Yes - There is a plan to make this available What will be shared: All data after concealment of the name can be shared When: 6 Month after publication To whom: Researchers in scientific centers Conditions: Every usage or analysis on the data is permitted with mentioning the source. Requests are sent through email Where to obtain: Send request to Dr. Mohammad Masoomzadeh through email address: mzmasoomzadeh@yahoo.com How to obtain: Send request email. I will respond within a week. Comments:
public Mohammad Masoomzadeh
No 68, North Sindokht street, North Kargar street, Tehran
Tehran Iran (Islamic Republic of) 1411933886 +98 31 3668 3368 mzmasoomzadeh@yahoo.com Tehran University of Medical Sciences scientific Mohammad Masoomzadeh
No 68, North Sindokht street, North Kargar street, Tehran
Tehran Iran (Islamic Republic of) 1411933886 +98 31 3668 3368 mzmasoomzadeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who underwent breast cancer surgery at Shariati hospital and Imam khomeini Cancer institute in 2019 no limit no limit Female 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 C50 Malignant neoplasm of breast Rehabilitation Rehabilitation Intervention group: 75 mg Pregabalin 1h before surgery orally then every 12h until 15 days after surgery Control group: 75 mg Placebo 1h before surgery orally then every 12h until 15 days after surgery Post op pain score after breast cancer surgery. Timepoint: 24h, 48h, 1w, 1m and 6 month after surgery. Method of measurement: Verbal Numerical Rating Scale (VNRS). Morphine usage. Timepoint: after surgery until discharge. Method of measurement: nurse's report. Tehran university of medical sciences Approved 2018-11-05 Ethics committee of Tehran university of Medical Sciences No 68, North Sindokht street, North Kargar Street, Tehran Tehran Tehran Iran (Islamic Republic of)