Clinical trial · Interventional
Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
NCT03393117CI-TRIAL-00046092withdrawnPhase 2ClinicalTrials.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): No accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Liposomal Bupivacaine | Drug | — | UNRESOLVED |
| Oral Narcotic | Drug | — | UNRESOLVED |
| Patient-Controlled Analgesia Pump | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liposomal Bupivacaine + Bupivacaine
- description
- This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
- interventionNames
- Drug: Liposomal Bupivacaine
- Drug: Bupivacaine
- Drug: Patient-Controlled Analgesia Pump
- Drug: Oral Narcotic
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine
- description
- This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
- interventionNames
- Drug: Bupivacaine
- Drug: Patient-Controlled Analgesia Pump
- Drug: Oral Narcotic
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled to have a unilateral, immediate breast reconstruction Exclusion Criteria: * Pregnant * Concurrent or recent medical condition that could interfere with study participation including: * Hepatitis * Alcohol/substance abuse * Uncontrolled psychiatric disorders * Known allergy * Contraindication to amide-type local anesthetics, opioids, or propofol. * Body weight of less than 50 kg * Participated in another study involving an investigational medication within the prior 30 days * Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.