Pregabalin in Treating Pain in Women Undergoing Mastectomy or Lumpectomy

OBJECTIVES:

Primary

- To evaluate the effects of pregabalin on postoperative opioid requirements and
opioid-related side effects in women undergoing mastectomy or lumpectomy.

Secondary

- To evaluate the effects of pregabalin on pain scores at 3 months after mastectomy or
lumpectomy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive an oral placebo 1-2 hours prior to surgery, at 12 hours after
surgery, and then twice daily for 14 days.

- Arm II: Patients receive oral pregabalin 1-2 hours prior to surgery, at 12 hours after
surgery, and then twice daily for 14 days.

In both arms, patients also receive IV morphine (patient-controlled analgesia [PCA]) for
rescue pain management during the immediate postoperative period. Beginning the day after
surgery, patients switch to oral hydrocodone/acetaminophen every 4 hours as needed for pain.

After surgery, patients are followed daily for 1 week and then on days 14, 30, and 90.

PROJECTED ACCRUAL: A total of 80 patients (40 patients in arm I and 40 patients in arm II)
will be accrued for this study.

DISEASE CHARACTERISTICS:

- Planning to undergo unilateral modified radical mastectomy or lumpectomy with
axillary node dissection

- No chronic pain

PATIENT CHARACTERISTICS:

- American Society of Anesthesiologists (ASA) physical status I-III

- Able to cooperate

- No known allergy to pregabalin or morphine

- No history of drug or alcohol abuse

- No impaired kidney function

PRIOR CONCURRENT THERAPY:

- No concurrent daily analgesics or steroids