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

Evaluating Pregabalin effect on post surgical patients who underwent breast cancer surgery

Clinical trial with control group, Parallel groups, double blinded, randomized, phase 3, on 150 patients, Randomization was based on Random allocation software

Place: Shariati hospital and Imam Khomeini cancer institute Procedure: Patients scheduled for breast surgery were given 75 mg pregabalin or placebo 1h before surgery and continued every 12 h for 15 days. Pain scores were obtained using Verbal numerical rating scale at specific times after surgery. Patients and researcher were blinded toward the drug. only pharmacotherapist knew the code of the drugs. it was revealed after data gathering.

Patients who underwent breast cancer surgery were enrolled in the study. Patients who didn't sign the consent or with history of seizure or previously using pregabalin or GFR less than 60 or patients who were unable to cooperate with data gathering were excluded.

Intervention group: 75 mg Pregabalin twice daily 15 days following surgery control group: 75 mg Placebo twice daily 15 days following surgery

Age؛ BMI؛ Morphine usage؛ surgery time؛ tumor size؛ Lymph node involvement؛ Hospital؛ Nausea؛ headache؛ Dizziness؛ blurred vision؛ neoadjuvant؛ Breast surgery type؛ Axillary surgery type؛ Addiction؛ Point of maximal pain؛ Pain scores at rest and arm abduction in 24h, 48h, 1w, 1M and 6 month after surgery

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.

Patients, Researcher, Doctors and nurses and Data gatherers were blind towards the drug. Evaluator and analyzer were not blind.

All data after concealment of the name can be shared

6 Month after publication

Researchers in scientific centers

Every usage or analysis on the data is permitted with mentioning the source. Requests are sent through email

Send request to Dr. Mohammad Masoomzadeh through email address: mzmasoomzadeh@yahoo.com

Send request email. I will respond within a week.

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.