Study of Pregabalin effect on breast cancer surgery
- Conditions
- Post op Pain after breast cancer surgery.Malignant neoplasm of breast
- Registration Number
- IRCT20200502047263N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 250
Patients who underwent breast cancer surgery at Shariati hospital and Imam khomeini Cancer institute in 2019
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Morphine usage. Timepoint: after surgery until discharge. Method of measurement: nurse's report.