Status:
COMPLETED
The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Breast Cancer Surgery
Post Operative Pain
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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, nonsteroidal antiinflammatory drugs, 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00852683
Start Date
May 1 2008
End Date
December 1 2013
Last Update
March 7 2014
Active Locations (1)
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1
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9