Pregabalin in Treating Pain in Women Undergoing Mastectomy or Lumpectomy - Full Text View

Sponsored by:	Simmons Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00631891

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Pain	Drug: placebo Drug: pregabalin	Phase III

MedlinePlus related topics: Cancer Mastectomy

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pain scores (VAS) and pain category as assessed at 3 months after mastectomy or lumpectomy [ Designated as safety issue: No ]
Morphine consumption (IV patient-controlled analgesia [PCA] and oral opioid dosage) [ Designated as safety issue: No ]
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) [ Designated as safety issue: Yes ]
Modified Brief Pain Inventory-short form [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2006
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Placebo Comparator Patients receive an oral placebo 1-2 hours prior to surgery, at 12 hours after surgery, and then twice daily for 14 days.	Drug: placebo Given orally
Arm II: Experimental Patients receive oral pregabalin 1-2 hours prior to surgery, at 12 hours after surgery, and then twice daily for 14 days.	Drug: pregabalin Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631891

Locations

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

Sponsors and Collaborators

Simmons Cancer Center

Investigators

Principal Investigator:

Babatunde Ogunnaike, MBBS

Simmons Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas ( Babatunde Ogunnaike )
Study ID Numbers:	CDR0000587495, SCCC-022006-010, PFIZER-SCCC-022006-010
Study First Received:	March 7, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00631891
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

pain
perioperative/postoperative complications

Study placed in the following topic categories:

Morphine
Postoperative Complications
Pregabalin
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009