Clinical trial · Interventional
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
NCT01231204CI-TRIAL-00021697completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
Conditions
Conditions (3)
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 |
| Mastectomy | — | UNRESOLVED | — |
| Paravertebral Catheter Insertion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (normal saline) Continuous Infusion | Procedure | — | UNRESOLVED |
| Ropivicaine 0.4% Continuous Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Infusion
- description
- Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
- interventionNames
- Procedure: Placebo (normal saline) Continuous Infusion
- type
- ACTIVE_COMPARATOR
- label
- Ropivicaine 0.4% Infusion
- description
- Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
- interventionNames
- Procedure: Ropivicaine 0.4% Continuous Infusion
Primary outcomes (1)
- measure
- Pain Scores (NRS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * undergoing unilateral or bilateral mastectomy * desiring analgesia with a paravertebral nerve block(s) * age 18 years or older * female Exclusion Criteria: * morbid obesity as defined by a body mass index \> 40 * renal insufficiency * chronic opioid use * history of opioid abuse * any comorbidity which results in moderate or severe functional limitation * inability to communicate with the investigators or hospital staff * pregnancy * incarceration
References
Publications (0)
Data not yet available
No reference posted for this study.