Chronic Post Breast Surgery Pain

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Paravertebral block; Procedure: Sham injections

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Block	Procedure: Paravertebral block; 3ml 1% Ropivacaine at each level T1 - T5
SHAM_COMPARATOR: Sham injection; Skin injections with Normal Saline	Procedure: Sham injections; Sham injections with Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Beth Ladlie, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (ESTIMATE): February 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2010
• Last Update Submitted That Met QC Criteria: June 10, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 08-004783