Post Operative Pain Clinical Trial
Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to
remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this
type is associated with pain both in the days immediately following the operation and in the
long term. Pain that continues for more than three months after surgery is known as chronic
pain and affects as many as 1/5 to more than ½ of patients having this surgery. Often this
pain is of a particular type known as neuropathic pain. There have been studies
demonstrating that the intensity of pain after surgery may be related to the likelihood of
developing chronic pain. It is important to develop methods to reduce acute pain after
breast cancer surgery and to reduce chronic pain for breast cancer survivors.
Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be
effective for neuropathic pain. There has also been one study demonstrating its
effectiveness in reducing pain after dental extraction. We are interested in determining
whether pregabalin taken for 14 days starting the day of surgery will reduce acute (short
term) pain and chronic pain from this type of breast cancer surgery.
In order to test ability of pregabalin for the reduction of chronic pain it may be necessary
to follow a large number of patients for up to one year after surgery. This may require
studying patients in more than one institution. Prior to starting such a large study we are
proposing a pilot or preliminary study. This study will follow a smaller group of
participants (68) for 6 months. From the pilot study we will determine the effect of
pregabalin on acute pain and logistic and statistical information required for the full
study. We will randomly assign participants to receive pregabalin or placebo (sugar pills)
for twice daily for 14 days starting one hour before surgery. We will monitor the
participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks,
three months and six months after surgery. We will also monitor for a number of other
parameters such as medication side effects and the need for other pain medications.
Recruitment of study participants is expected to take 6-7 months.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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