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A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.


N/A
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Beth Ladlie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic Florida

Authority:

United States: Institutional Review Board

Study ID:

08-004783

NCT ID:

NCT00847067

Start Date:

February 2009

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic FloridaJacksonville, Florida  32224