Chronic Post Breast Surgery Pain

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00847067

Enrollment

Registered

2009-02-19

Start date

2009-02-28

Completion date

2010-04-30

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

PROCEDUREParavertebral block

3ml 1% Ropivacaine at each level T1 - T5

PROCEDURESham injections

Sham injections with Normal Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026