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TerminatedNCT00847067Updated Jun 11, 2010

Chronic Post Breast Surgery Pain

An interventional study of Paravertebral block and Sham injections in Breast Cancer, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-11.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Why this study was terminated
Funding not renewed
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Block

    Procedure: Paravertebral block

  • Sham comparator
    Sham injection

    Skin injections with Normal Saline

    Procedure: Sham injections

Interventions

  • ProcedureParavertebral block

    3ml 1% Ropivacaine at each level T1 - T5

  • ProcedureSham injections

    Sham injections with Normal Saline

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00847067
Lead sponsor
Mayo Clinic
First posted
Feb 19, 2009
Start date
Feb 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Jun 11, 2010

Study contacts

Beth Ladlie, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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