Chronic Post Breast Surgery Pain

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: NCT00847067
Recruitment Status : Terminated (Funding not renewed)
First Posted : February 19, 2009
Last Update Posted : June 11, 2010
Information provided by:
Mayo Clinic

Brief Summary:
The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the CNS during surgery and the immediate post-operative period.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Paravertebral block Procedure: Sham injections Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.
Study Start Date : February 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Block Procedure: Paravertebral block
3ml 1% Ropivacaine at each level T1 - T5
Sham Comparator: Sham injection
Skin injections with Normal Saline
Procedure: Sham injections
Sham injections with Normal Saline

Primary Outcome Measures :
  1. To obtain practical experience and information with which to develop a larger, more definitive study, particularly with regard to distributions of VAS responses at 3 months, patient compliance, and achievable accrual rate. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female patient who are ≥ 18 and ≤ 80 years of age.
  2. Patient with diagnosis of breast cancer.
  3. Patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection
  4. Patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection
  5. Patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction.

Exclusion Criteria:

  1. Pre-existing peripheral neuropathy
  2. Pre-existing chronic pain
  3. Bilateral procedure
  4. Previous breast surgery, except biopsy
  5. Inability to read, write or speak English.
  6. Allergy to amide local anesthetics
  7. Contraindications to paravertebral nerve block including, but not limited to severe scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation studies (some of these may not be known until after informed consent is obtained)
  8. Pregnancy
  9. Emergency surgery
  10. Previous recipients of peripheral nerve block.
  11. Medical professional whose experience includes caring for patients who have had peripheral nerve blocks.

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): NCT00847067

United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Beth Ladlie, MD Mayo Clinic Florida

Responsible Party: Beth Ladlie, MD, Mayo Clinic Florida Identifier: NCT00847067     History of Changes
Other Study ID Numbers: 08-004783
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010