Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy
18 Years
70 Years
Female
Pain, Perioperative/Postoperative Complications
Trial Information
Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Pain scores (VAS) and pain category as assessed at 3 months after mastectomy or lumpectomy
Safety Issue:
No
Principal Investigator
Babatunde Ogunnaike, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Simmons Cancer Center
Authority:
Unspecified
Study ID:
CDR0000587495
NCT ID:
NCT00631891
Start Date:
December 2006
Completion Date:
Related Keywords:
- Pain
- Perioperative/Postoperative Complications
- pain
- perioperative/postoperative complications
- Postoperative Complications
Name | Location |
|---|---|
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
