The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer Surgery; Post Operative Pain After Axillary Node Dissection
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Capital District Health Authority, Canada Official(s) and/or principal investigator(s):
Peter MacDougall, Principal Investigator, Affiliation: Capital District Health Authority
Overall contact:
Peter MacDougall, MD, Phone: 902-473-2331, Email: pmacdou@dal.ca
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Primary outcome: The primary outcome will be reduction in Numeric Rating Score (22, 23) at rest (NRS-R) and with movement (NRS-M) 24 hours after surgery. NRS-M is defined as pain with cough or deep inspiration, whichever is greatest.
Secondary outcome: Incidence of chronic post-mastectomy pain at 3 months defined as persistent pain or discomfort not present prior to surgery and not present as a result of new or recurrent tumour growth.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients 18-60 years of age, ASA I-III undergoing breast surgery with axillary
dissection for the treatment of breast cancer will be considered eligible for the
study.
- Informed consent for the study will be obtained prior to surgery.
Exclusion Criteria:
The following persons will not be considered for inclusion in the study:
- Persons undergoing breast surgery for breast cancer without axillary dissection.
- Persons undergoing cosmetic breast surgery.
- Persons undergoing concurrent breast reconstruction.
- Persons undergoing reconstruction within 12 months of surgery.
- Persons with a history of allergy to gabapentin or pregabalin.
- Persons with a history of allergy to morphine, NSAID, acetaminophen or oxycodone.
- Persons who are or may be pregnant.
- Persons with a BMI >40.
- Persons with severe organ dysfunction such as liver and renal failure.
- Persons receiving greater than or equal to 30 mg per day of morphine (or equivalent
opioid) for pre-existing pain conditions.
- Persons previously on gabapentin or pregabalin within 3 months of surgery.
- Persons with a history of drug abuse. 13) Persons who are unable to communicate in
English.
Locations and Contacts
Peter MacDougall, MD, Phone: 902-473-2331, Email: pmacdou@dal.ca
Capital District Health Authority, Halifax, Nova Scotia B3H 2Y9, Canada; Recruiting
Peter MacDougall, MD, Phone: 902-473-2331, Email: pmacdou@dal.ca
Additional Information
Capital District Health Authority
Starting date: May 2008
Ending date: December 2009
Last updated: July 9, 2009
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