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Phase 3
18 Years
60 Years
Open (Enrolling)
Breast Cancer Surgery, Post Operative Pain

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Trial Information

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

- 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, 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Peter MacDougall

Investigator Role:

Principal Investigator

Investigator Affiliation:

Capital District Health Authority, Canada


Canada: Health Canada, Office of Clinical Trials

Study ID:




Start Date:

May 2008

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer Surgery
  • Post Operative Pain
  • Breast Neoplasms
  • Pain, Postoperative