Chronic Post Breast Surgery Pain

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: Paravertebral block; Procedure: Sham injections

• Registration Number: NCT00847067
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 40

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.

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block	Paravertebral block	-
Sham injection	Sham injections	Skin injections with Normal Saline

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States