Breast Cancer, Breast Cancer Female
Conditions
Keywords
Mastectomy, Double Mastectomy, Mastectomy with reconstruction, Double mastectomy with reconstruction, Double mastectomy with immediate reconstruction, Mastectomy with immediate reconstruction, Memorial Sloan Kettering Cancer Center, 19-238
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.
Interventions
DRUGPVB Protocol
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.
DRUGPECS-1
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
DRUGSerratus
For the serratus block, the patient will be placed in the supine or lateral decubitus position and with an ultrasound probe, in the parasagittal plane, the serratus muscles will be identified. Injections will be done in-plane below the serratus anterior.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to 1 of 3 groups (approximately n=500 patients per group) of standard of care preoperative nerve blocks consisting of either: i) PVB, ii) serratus+PECS-1, or iii) PVB+PECS-1. Each group will receive ropivacaine or bupivacaine +/- clonidine (0.5 - 1 mcg/kg not to exceed a total of 100 mcg) +/- dexamethasone (up to 4 mg) in one of three routine nerve block approaches prior to surgical procedure as is current standard of care.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare Preoperative Nerve Blocks Between a Combination of Nerve Blocks and PVB Alone to Decrease Postoperative Opioid Consumption | 2 days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHanae Tokita, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 120 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1234 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 98 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants |
| Race (NIH/OMB) White | 1194 Participants |
| Region of Enrollment United States | 568 Participants |
| Sex: Female, Male Female | 1506 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 492 | 0 / 446 | 0 / 568 |
| other Total, other adverse events | 0 / 492 | 0 / 446 | 0 / 568 |
| serious Total, serious adverse events | 0 / 492 | 0 / 446 | 1 / 568 |
Outcome results
None listed