Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

NCT00785382 | Completed Phase 4 DMC

• 1 other identifier: IWK-4298-2008
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?

Conditions

Postoperative Pain

Keywords

Pain, Pregabalin, Lyrica, Breast surgery

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.

  24 hours

Secondary Outcomes (1)

• NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation

  48 hours

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: Pregabalin 150 mg

Interventions

Placebo DRUG

Lactulose Placebo

1

Pregabalin 150 mg DRUG

150 mg Q12H x 2 doses

Also known as: Lyrica

2

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesia physical status class I \& II
• Age ¬\< 65 years
• English-speaking
• Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)

You may not qualify if:

• Known or suspected allergy, sensitivity, or contraindication to pregabalin
• Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
• Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
• History of a seizure disorder
• Pregnancy
• Current pre-operative therapy with pregabalin, gabapentin, or any opioid
• Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
• CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Ronald B George, MD FRCPC

  IWK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

CA (1)