Breast CancerPhase 4NCT04016376
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
A Phase 4 study testing PVB Protocol, PECS-1 and Serratus in people with Breast Cancer and Breast Cancer Female, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- What is being tested?
- PVB Protocol, PECS-1 and Serratus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,507 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 25 Feb 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None applicable, as exclusion occurs prior to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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
- Breast Cancer, Breast Cancer Female
- Being tested
- PVB Protocol, PECS-1, Serratus
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVB ProtocolDrug
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.
PECS-1Drug
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
SerratusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PVB | Experimental | 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. Receives: Drug: PVB Protocol |
| PVB + PECS-1 | Experimental | 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. Receives: Drug: PVB Protocol; Drug: PECS-1 |
| Serratus + PECS-1 | Experimental | 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.
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. Receives: Drug: PECS-1; Drug: Serratus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Preoperative Nerve Blocks Between a Combination of Nerve Blocks and PVB Alone to Decrease Postoperative Opioid Consumption
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start5 Jul 2019
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanae Tokita, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016376
- Sponsor's protocol ID
- 19-238
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2019
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Tokita 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.
PubMed 41212546Tokita 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.
PubMed 38895970
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04016376
- Acronym / sponsor ID
- 19-238
- Conditions
- Breast Cancer, Breast Cancer Female
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PVB | Experimental | Drug: PVB ProtocolPatient 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. |
| PVB + PECS-1 | Experimental | Drug: PVB Protocol, Drug: PECS-1Patient 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. |
| Serratus + PECS-1 | Experimental | Drug: PECS-1, Drug: SerratusFor 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. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None applicable, as exclusion occurs prior to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVB ProtocolPatient 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. | Drug | PVB, PVB + PECS-1 |
| PECS-1For 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 | Drug | PVB + PECS-1, Serratus + PECS-1 |
| SerratusFor 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. | Drug | Serratus + PECS-1 |
Primary outcome
Compare Preoperative Nerve Blocks Between a Combination of Nerve Blocks and PVB Alone to Decrease Postoperative Opioid Consumption
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41212546Tokita 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.
- Derived from this study: PubMed 38895970Tokita 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanae Tokita, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVB Protocol, PECS-1 and Serratus in people with Breast Cancer and Breast Cancer Female, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Preoperative Nerve Blocks Between a Combination of Nerve Blocks and PVB Alone to Decrease Postoperative Opioid Consumption (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016376, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.