Chronic Post Breast Surgery Pain

Mayo Clinic

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: Paravertebral block; Procedure: Sham injections

Study type: Interventional

Funder types: Other

Identifiers

NCT00847067

08-004783

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Block

Active Comparator group

Treatment:

Procedure: Paravertebral block

Sham injection

Sham Comparator group

Description:

Skin injections with Normal Saline

Treatment:

Procedure: Sham injections