Clinical Trial: NCT04016376
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
Status:
COMPLETEDPhase:
Phase 4| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
| Information Provided By: | Memorial Sloan Kettering Cancer Center |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
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.
Official Title
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
Conditions
Breast Cancer, Breast Cancer Female
Intervention / Treatment
- Drug: PVB Protocol
- Drug: PECS-1
- Drug: Serratus
Other Study ID Numbers
- 19-238
Start Date (Actual)
2019-07-05
Primary Completion Date (Actual)
2026-02-25
Study Completion Date (Actual)
2026-02-25
Enrollment (Actual)
1507
Study Type
Interventional
Phase
Phase 4
| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
| Information Provided By: | Memorial Sloan Kettering Cancer Center |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
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.
Official Title
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
Conditions
Breast Cancer, Breast Cancer Female
Intervention / Treatment
- Drug: PVB Protocol
- Drug: PECS-1
- Drug: Serratus
Other Study ID Numbers
- 19-238
Start Date (Actual)
2019-07-05
Primary Completion Date (Actual)
2026-02-25
Study Completion Date (Actual)
2026-02-25
Enrollment (Actual)
1507
Study Type
Interventional
Phase
Phase 4