The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852683
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):
Peter MacDougall, Nova Scotia Health Authority

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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Surgery Post Operative Pain Drug: Pregabalin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: Pregabalin
75 mg twice a day
Placebo Comparator: B Drug: Placebo
75 mg twice a day

Primary Outcome Measures :
  1. 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. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852683

Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: Peter MacDougall Nova Scotia Health Authority

Additional Information:
Responsible Party: Peter MacDougall, MD, FRCPC, Nova Scotia Health Authority Identifier: NCT00852683     History of Changes
Other Study ID Numbers: CDHA-RS/2007-374
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs