Chronic Post Breast Surgery Pain

NCT00847067 | Terminated

• 1 other identifier: 08-004783
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

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.

  3 months

Study Arms (2)

Block

ACTIVE COMPARATOR

Procedure: Paravertebral block

Sham injection

SHAM COMPARATOR

Skin injections with Normal Saline

Procedure: Sham injections

Interventions

Paravertebral block PROCEDURE

3ml 1% Ropivacaine at each level T1 - T5

Block

Sham injections PROCEDURE

Sham injections with Normal Saline

Sham injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient who are ≥ 18 and ≤ 80 years of age.
• Patient with diagnosis of breast cancer.
• Patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection
• Patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection
• Patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction.

You may not qualify if:

• Pre-existing peripheral neuropathy
• Pre-existing chronic pain
• Bilateral procedure
• Previous breast surgery, except biopsy
• Inability to read, write or speak English.
• Allergy to amide local anesthetics
• 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)
• Pregnancy
• Emergency surgery
• Previous recipients of peripheral nerve block.
• Medical professional whose experience includes caring for patients who have had peripheral nerve blocks.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Beth Ladlie, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)