Clinical trial · Interventional
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
Cluster-Randomized, Prospective Assessment of Postoperative Pain Management in Patients Undergoing Bilateral Mastectomy With Immediate Reconstruction With Tissue Expander (BMWRw/TE) Using Preoperative Paravertebral (PVB), Serratus+PECS-1, or PVB+PECS-1 Nerve Blocks
NCT04016376CI-TRIAL-00126083completedPhase 4Results postedClinicalTrials.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)
The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication after surgery.
Conditions
Conditions (2)
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 |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PECS-1 | Drug | — | UNRESOLVED |
| PVB Protocol | Drug | — | UNRESOLVED |
| Serratus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- PVB
- description
- Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes.
- interventionNames
- Drug: PVB Protocol
- type
- EXPERIMENTAL
- label
- PVB + PECS-1
- description
- Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes. For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \>/= 18 years old * Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR) * Scheduled for surgery at Josie Robertson Surgical Center (JRSC) * Must be appropriate for an agree to receive a nerve block * Must be appropriate for randomization * Able to read and speak English * Willing and able to provide written informed consent Exclusion Criteria: * None applicable, as exclusion occurs prior to consent
References
Publications (2)
- DERIVEDTokita HK, Assel MJ, Serafin J, Lin E, Sarraf L, Masson G, Nelson JA, Moo TA, McCready T, Vakassi C, Hingula L, Jackson J, Horine S, Baqai-Stern A, Lewis A, Nadav D, Teng H, Kim J, Hagen J, Scanlon M, Puttanniah V, Legler A, Gauran C, Simon BA, Vickers A. Paravertebral or Serratus Anterior Plane Block Combined with Interpectoral Blocks versus Paravertebral Block for Mastectomy: A Cluster-randomized Trial of 1,507 Patients. Anesthesiology. 2026 Feb 1;144(2):379-389. doi: 10.1097/ALN.0000000000005842. Epub 2025 Nov 10. PMID 41212546
- DERIVEDTokita HK, Assel M, Serafin J, Lin E, Sarraf L, Masson G, Moo TA, Nelson JA, Simon BA, Vickers AJ. Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment. Clin Trials. 2025 Feb;22(1):57-65. doi: 10.1177/17407745241255087. Epub 2024 Jun 19. PMID 38895970