Dallas, Texas 75390


Purpose:

RATIONALE: Pregabalin may help lessen pain caused by cancer surgery. It is not yet known whether pregabalin is more effective than standard therapy in lessening pain after cancer surgery. PURPOSE: This randomized phase III trial is studying how well pregabalin works in treating pain in women undergoing mastectomy or lumpectomy.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00631891


Primary Contact:

Principal Investigator
Babatunde Ogunnaike, MBBS
Simmons Cancer Center


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States

Clinical Trials Office - Simmons Comprehensive Cancer Center a
Phone: 866-460-4673; 214-648-7097

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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