Randomized, double-blind trial of preoperative pregabalin versus placebo to improve quality of recovery after breast cancer surgery

Abstract

Introduction

Surgery remains one of the most important treatments for breast cancer. In this context, the quality of postoperative recovery has become a key concern. Adequate control of acute pain is essential to optimize patient comfort and recovery. Pregabalin may contribute to this goal by preventing central sensitization and reducing perioperative anxiety.

Objectives

To evaluate the effect of perioperative pregabalin versus placebo on postoperative recovery quality in patients undergoing breast cancer surgery.

Method

In this randomized controlled trial, 92 patients received either pregabalin (150 mg orally, 1 hour before surgery) or a matching placebo, both prepared in identical capsules. The primary outcome was the QoR-15 score measured preoperatively, and at 24 and 48 hours postoperatively. The 24- and 48-hour assessments were conducted via telephone. The QoR-15 is a validated instrument that assesses the quality of recovery, with total scores ranging from 0 (very poor recovery) to 150 (excellent recovery). Secondary outcomes included opioid consumption, pain scores, incidence of nausea and vomiting, and lengths of stay in the Post-Anesthesia Care Unit (PACU) and hospital. An exploratory analysis of longitudinal changes in QoR-15 scores within each group was also performed. Analyses were performed per protocol.

Results

Eighty-four patients completed the study. There were no differences in overall QoR-15 score between the groups at any of the three assessment time points (preoperative, 24h, and 48h). In the exploratory longitudinal within-group analysis, better maintenance of recovery quality was observed in the pregabalin group compared with baseline, with medians (IQR) of 138 (122.3–145), 132.5 (125.8–135.3), and 134 (131.5–136) [p = 0.006 between 24h and 48h]. In the placebo group, the medians (IQR) were 140 (128–145.3), 129 (126–134.3), and 134 (126.8–136.3) [p = 0.002 between pre and 24h; p = 0.026 between pre and 48h].

Conclusion

Although exploratory analysis showed a trend toward improvement within the pregabalin group, there was no significant difference in QoR-15 scores between groups.