Clinical trial · Interventional
Chronic Post Breast Surgery Pain
A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.
NCT00847067CI-TRIAL-00003557terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding not renewed
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paravertebral block | Procedure | — | UNRESOLVED |
| Sham injections | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Block
- interventionNames
- Procedure: Paravertebral block
- type
- SHAM_COMPARATOR
- label
- Sham injection
- description
- Skin injections with Normal Saline
- interventionNames
- Procedure: Sham injections
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.