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

Sponsor:	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
Pain Perioperative/Postoperative Complications	Drug: pregabalin Other: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mastectomy

Drug Information available for: Pregabalin

U.S. FDA Resources

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.	Other: 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

Additional Information:

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

No publications provided

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:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00631891 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

pain
perioperative/postoperative complications

Additional relevant MeSH terms:

Pathologic Processes
Postoperative Complications
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Pregabalin

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010