Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Babatunde Ogunnaike, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01391858
First received: June 27, 2011
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

This study will compare the effects of oral pregabalin with placebo on postoperative pain and morphine usage after mastectomy.

Pregabalin is an anticonvulsant agent approved by the United States Food and Drug Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy.

Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with axillary node dissection will be recruited to participate in the study. Patients unable to cooperative, those that have known allergy to pregabalin or morphine and a history of drug or alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired kidney function will all be excluded from the study. A pregnancy test will also be performed to exclude pregnant women from the study.

Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be administered twice daily until day 14. Whether a patient receives pregabalin or placebo will be decided based on a process similar to tossing a coin.

Patients will receive a standard general anesthetic for their operation and will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. Oral opioids will be administered after discontinuation of the PCA.

Subjects will be visited after the operation while in the hospital and intermittently for three months at the outpatient clinic after discharge from the hospital. Subjects will be asked to return remaining study drug/empty container when they are at the hospital for their 2 week follow up visit.

Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema, weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all patients for the occurrence of these side effects.


Condition Intervention Phase
Post-operative Pain
Drug: lyrica
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The Postoperative Opioid Requirement After Mastectomy [ Time Frame: Postoperative Day (POD) 0 to POD1 ] [ Designated as safety issue: Yes ]
    IV-PCA morphine for rescue pain management in the immediate postoperative period after mastectomy

  • Oral Opioids Consumption [ Time Frame: Postoperative Day1 to hospital discharge ] [ Designated as safety issue: Yes ]
    Oral opioids consumption 24 hrs. after mastectomy to hospital discharge.


Enrollment: 80
Study Start Date: December 2006
Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pregabalin
pregabalin (lyrica)
Drug: lyrica
150mg of pregabalin/placebo
Other Name: pregabalin
Placebo Comparator: placebo
placebo
Drug: lyrica
150mg of pregabalin/placebo
Other Name: pregabalin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women, 18-70 years of age
  2. ASA physical status I to III
  3. Undergoing unilateral modified radical mastectomy or lumpectomy with axillary node dissection

Exclusion Criteria:

  1. Patients unable to cooperate
  2. Have known allergy to pregabalin or morphine
  3. A history of drug or alcohol abuse
  4. History of chronic pain
  5. Daily intake of analgesics or steroids
  6. Impaired kidney function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391858

Locations
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9068
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Pfizer
Investigators
Principal Investigator: Babatunde Ogunnaike, M.D. University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Babatunde Ogunnaike, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01391858     History of Changes
Obsolete Identifiers: NCT00631891
Other Study ID Numbers: 2004-0643
Study First Received: June 27, 2011
Results First Received: December 31, 2013
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Pregabalin
Postoperative pain
Mastectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014