PEP Topic 
Acute Pain

Pregabalin is an anticonvulsant used to treat certain types of seizures and, with other medications, to relieve neuropathic pain. Pregabalin works by decreasing the number of pain signals that damaged nerves send out. Available as a capsule to take by mouth, pregabalin has been studied as an intervention for pain and peripheral neuropathy in patients with cancer. Researchers have also studied the effect of the drug on anxiety and sleep-wake disturbances.

Effectiveness Not Established

Research Evidence Summaries

Kim, S.Y., Song, J.W., Park, B., Park, S., An, Y.J., & Shim, Y.H. (2011). Pregabalin reduces post-operative pain after mastectomy: A double-blind, randomized, placebo-controlled study. Acta Anaesthesiologica Scandinavica, 55(3), 290–296.

doi: 10.1111/j.1399-6576.2010.02374.x

Study Purpose:

To investigate the safety and effectiveness of pregabalin for reducing postoperative pain in patients who have undergone mastectomy

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to receive either pregabalin or placebo at 1 hour before surgery and at 12 hours after the initial dose. All patients received the same anesthesia and all received 100 mg aceclofenac twice a day the day after surgery. Assessment of pain and for adverse effects was done at 1, 6, 24, and 48 hours postoperatively. If a patient’s pain intensity was 5 or greater or if the patient requested analgesia, additional pain medication was provided. After discharge from the hospital, at one week and one month postoperatively, patients were contacted by phone for pain scoring.

Sample Characteristics:

  • The sample was composed of 84 patients.
  • Mean patient age was 50 years (SD = 8 years).
  • All patients were female.
  • All patients had breast cancer and underwent mastectomy during the study.


  • Single site
  • Inpatient
  • South Korea

Study Design:

Double-blind placebo-controlled randomized study

Measurement Instruments/Methods:

  • 11-point verbal rating scale, to rate pain
  • 4-point scale, to rate severity of side effects


  • At 1, 24, and 48 hours postoperatively, scores for pain at rest were lower in the pregabalin group than in the placebo group (P < 0.05). At the same general time periods, pain with movement was lower in the pregabalin group than in the placebo group.
  • Average differences in pain scores between groups were 1 point at most measurement periods. In the pregabalin group, pain intensity at one week postoperatively was 2 points lower on average than that in the placebo group.
  • Compared to patients in the placebo group, fewer patients in the pregabalin group required rescue analgesics during the first 48 hours after surgery, but this difference was not significant.
  • There were no differences in pain scores at six hours postoperatively, a fact that may have been due to the timing of premedication and the half-life of pregabalin.
  • There were no differences between groups in sedation scores or other side effects.


Perioperative pregabalin may improve postoperative pain control in patients who have undergone mastectomy.


  • The study had a small sample size, with fewer than 100 patients.
  • Authors did not analyze total use of rescue analgesics, so actual differences between groups, in regard to total analgesic needs, is undetermined.
  • The study included no subgroup analysis of patients who had partial versus total mastectomy or axillary lymph node dissection or not. Patients who had more extensive surgery would probably have more pain. Each group contained similar numbers of patients who had undergone surgery of the same extent.

Nursing Implications:

Perioperative administration of pregabalin may be helpful in the management of postoperative pain. This study does not establish the most effective timing of administration. Nurses should be aware of the common side effects of pregabalin (dizziness and sedation), which other studies have established. These side effects may complicate postanesthesia assessment.