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OpenTrials
Completed

NCT Number: NCT00785382

Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

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?

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Key information

Conditions

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

Age range

Up to 65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)))]

Treatment and study plan

Placebo

Drug

Lactulose Placebo

Pregabalin 150 mg

Drug

150 mg Q12H x 2 doses

Other names: Lyrica

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.

    Time frame: 24 hours

Secondary outcomes

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

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2008
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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