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
Recruitment status was Recruiting
Sponsor:
Simmons Cancer Center
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
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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 May 19, 2013