Pregabalin in Treating Pain in Women Undergoing Mastectomy or Lumpectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00631891
First received: March 7, 2008
Last updated: May 9, 2009
Last verified: May 2009
  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 3

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

Resource links provided by NLM:


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
Placebo Comparator: 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.
Other: placebo
Given orally
Experimental: Arm II
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:
No publications provided

Responsible Party: Babatunde Ogunnaike, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier: NCT00631891     History of Changes
Other Study ID Numbers: CDR0000587495, SCCC-022006-010, PFIZER-SCCC-022006-010
Study First Received: March 7, 2008
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
pain
perioperative/postoperative complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014