Pregabalin in Treating Pain in Women Undergoing Mastectomy or Lumpectomy

Condition(s) targeted: Cancer-Related Problem/Condition; Pain

Intervention: placebo (Drug); pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Simmons Cancer Center

Official(s) and/or principal investigator(s):
Babatunde Ogunnaike, MBBS, Principal Investigator, Affiliation: Simmons Cancer Center

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.

Official title: Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome:

Pain scores (VAS) and pain category as assessed at 3 months after mastectomy or lumpectomy

Morphine consumption (IV patient-controlled analgesia [PCA] and oral opioid dosage)

Side effects as assessed by the symptom distress questionnaire, which includes measures of frequency, intensity, and bothersomeness evaluated on a four-point verbal scale (none, mild, moderate, severe)

Modified Brief Pain Inventory-short form

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States; Recruiting
Clinical Trials Office - Simmons Comprehensive Cancer Center a, Phone: 866-460-4673; 214-648-7097

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2006
Last updated: October 18, 2008