Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica

NCT01391858 | Completed Phase 3 Results DMC

• 1 other identifier: 2004-0643
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain

Keywords

Pregabalin; Postoperative pain; Mastectomy

Outcome Measures

Primary Outcomes (2)

• The Postoperative Opioid Requirement After Mastectomy

  IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy

  Participants received PCA pump, an average of 24 hrs after mastectomy

• Oral Opioids Consumption

  Oral opioids consumption after mastectomy until hospital discharge.

  Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy

Secondary Outcomes (6)

• Pain Scores

  Participants' pain score was assessed on the first postoperative day after mastectomy

• Pain Scores

  Participants' pain score was assessed at hospital discharge, an average of 3 days after mastectomy

• Pain Scores

  Participants' pain score was assessed after discharge on the 7th day after mastectomy

• Pain Scores

  Participants' pain score was assessed after discharge on the 14th day after mastectomy

• Pain Scores

  Participants' pain score was assessed after discharge on the 30th day after mastectomy

Study Arms (2)

pregabalin

ACTIVE COMPARATOR

pregabalin (lyrica)

Drug: lyrica

placebo

PLACEBO COMPARATOR

placebo

Drug: lyrica

Interventions

lyrica DRUG

150mg of pregabalin/placebo

Also known as: pregabalin

placebo; pregabalin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unable to cooperate
• Have known allergy to pregabalin or morphine
• A history of drug or alcohol abuse
• History of chronic pain
• Daily intake of analgesics or steroids
• Impaired kidney function

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Babatunde Ogunnaike
• Organization: UTexas Southwestern Medical Center

Babatunde.Ogunnaike@UTSouthwestern.edu

(214) 590

Study Officials

• Babatunde Ogunnaike, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 12, 2011
• Study Start: December 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 12, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-08

Locations

US (1)