Chronic Post Breast Surgery Pain

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00847067
• Other study ID #: 08-004783
• Status: Terminated
• Phase: N/A
• First received: February 18, 2009
• Last updated: June 10, 2010
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Paravertebral block
3ml 1% Ropivacaine at each level T1 - T5
• Sham injections
Sham injections with Normal Saline

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No