The Possible Preventive Role of Pregabalin in Postmastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial.

CONTEXT

Chronic postmastectomy pain syndrome (PMPS) has a considerable negative impact on the quality of life of breast cancer patients.

OBJECTIVE

The objective of this study was to assess the possible preventive role of perioperative pregabalin in PMPS.

METHODS

This randomized controlled study included 200 patients with breast cancer scheduled for elective breast cancer surgery. They were randomly assigned to one of two treatment groups. The pregabalin group received 75 mg of pregabalin twice daily for seven days and the control group received oral equivalent placebo capsules. The primary outcome was development of neuropathic PMPS. Neuropathic pain was assessed using the Grading System for Neuropathic Pain. Secondary outcome measures were safety and Visual Analogue Scale scores.

RESULTS

Neuropathic pain was significantly less frequent in the pregabalin group compared to the control group at four weeks (P = 0.005), 12 weeks (P = 0.002), and 24 weeks (P < 0.001) postoperatively. PMPS was diagnosed in 11 patients (11%) of the pregabalin group and 29 patients (29%) of the control group (P < 0.001, relative risk: 0.26, 95% CI: 0.12-0.56). At the three follow-up time points, Visual Analogue Scale scores during the first three postoperative weeks were comparable in both groups while they were significantly lower in the pregabalin group at 4, 12, and 24 weeks. These two groups were comparable in the frequency of adverse events (P = 0.552).

CONCLUSION

Perioperative oral pregabalin 75 mg twice daily, starting at the morning of surgery and continued for one week, could reduce the frequency of postmastectomy pain syndrome.