Breast CancerPhase 3NCT03351348
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
A Phase 3 study testing Bupivacaine, patient-reported pain scores and saline in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bupivacaine, patient-reported pain scores and saline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Nov 2017to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients ≥ 18 years of age
- Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
- Patients scheduled for surgery at the JRSC or MSK Monmouth
- Previously enrolled patients > 6 months from contralateral mastectomy
Who cannot join
- Patients who are non-English speaking
- Patients having any immediate breast reconstructive procedure
- Patients are having bilateral mastectomy
- Patients who report a baseline pain score > 3, unrelated to a breast procedure
- Patients who take long acting opioid medication use
- Patients will be excluded if they are having their mastectomy performed with tumescence
- Patients weighing < 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose
- Patients within 6 months of previous enrollment for surgery for contralateral mastectomy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and follow-up only)
East White Plains, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and follow-up only)
Uniondale, New York, 11553
About this study
Official title: Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction
The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
- Conditions
- Breast Cancer
- Being tested
- Bupivacaine, patient-reported pain scores, saline
- Keywords
- Bupivacaine, Mastectomy, Sentinel lymph node biopsy SLNB, 17-576
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
patient-reported pain scoresBehavioural
Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).
salineOther
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
| Study group | Role | What they receive |
|---|---|---|
| Saline + usual post-operative medications | Active comparator | The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. Receives: Behavioral: patient-reported pain scores; Other: saline |
| Bupivacaine + usual post-operative medications | Experimental | The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. Receives: Drug: Bupivacaine; Behavioral: patient-reported pain scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients that have moderate to severe pain
Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain.
0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start16 Nov 2017
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, double-blind, randomized, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Kirstein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351348
- Sponsor's protocol ID
- 17-576
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2017
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction
- ClinicalTrials.gov ID
- NCT03351348
- Acronym / sponsor ID
- 17-576
- Conditions
- Breast Cancer
- Keywords
- Bupivacaine, Mastectomy, Sentinel lymph node biopsy SLNB, 17-576
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
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 compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, double-blind, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Saline + usual post-operative medications | Active comparator | Behavioral: patient-reported pain scores, Other: salineThe intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. |
| Bupivacaine + usual post-operative medications | Experimental | Drug: Bupivacaine, Behavioral: patient-reported pain scoresThe intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
- Patients scheduled for surgery at the JRSC or MSK Monmouth
- Previously enrolled patients > 6 months from contralateral mastectomy
Key exclusion criteria (8 listed)
- Patients who are non-English speaking
- Patients having any immediate breast reconstructive procedure
- Patients are having bilateral mastectomy
- Patients who report a baseline pain score > 3, unrelated to a breast procedure
- Patients who take long acting opioid medication use
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 |
|---|---|---|
| BupivacaineThe intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. | Drug | Bupivacaine + usual post-operative medications |
| patient-reported pain scoresWill be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients). | Behavioural | Bupivacaine + usual post-operative medications, Saline + usual post-operative medications |
| salineThe intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection. | Other | Saline + usual post-operative medications |
Primary outcome
number of patients that have moderate to severe pain
Time frame: up to 24 hours
Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain. 0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Laurie Kirstein, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine, patient-reported pain scores and saline in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
number of patients that have moderate to severe pain (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.