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Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Pain, Perioperative/Postoperative Complications

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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 - DallasDallas, Texas  75390