Chronic Post Breast Surgery Pain

This study has been terminated.
(Funding not renewed)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00847067
First received: February 18, 2009
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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 Intervention
Breast Cancer
Procedure: Paravertebral block
Procedure: Sham injections

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847067

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

No publications provided

Responsible Party: Beth Ladlie, MD, Mayo Clinic Florida
ClinicalTrials.gov Identifier: NCT00847067     History of Changes
Other Study ID Numbers: 08-004783
Study First Received: February 18, 2009
Last Updated: June 10, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014