Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Pregabalin in Treating Pain in Women Undergoing Mastectomy or Lumpectomy

Basic Trial Information

Objectives

Primary

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

Secondary

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

Entry Criteria

Disease Characteristics:

• Planning to undergo unilateral modified radical mastectomy or lumpectomy with axillary node dissection
• No chronic pain

Prior/Concurrent Therapy:

• No concurrent daily analgesics or steroids

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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Babatunde Ogunnaike, MBBS, Principal investigator		Ph: 214-590-8536; 866-460-4673

U.S.A.
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097

Registry Information
Official Title		Effects of Oral Pregabalin versus Placebo on Postoperative Pain and Morphine Consumption after Mastectomy
Trial Start Date		2006-12-22
Trial Completion Date		2009-05-29 (estimated)
Registered in ClinicalTrials.gov		NCT00631891
Date Submitted to PDQ		2008-02-06
Information Last Verified		2009-05-03

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