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NCT03351348 · ClinicalTrials.gov registry record · Phase 3
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
A Phase 3 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
- 7
- Study locations
NCT03351348: Recruiting Phase 3 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03351348 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 165 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03351348, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
- 7
- Study locations
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Bupivacaine
- BEHAVIORAL patient-reported pain scores
- OTHER saline
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Consent and follow-up only) - Commack
- Memorial Sloan Kettering Westchester (Consent and follow-up only) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Consent and follow-up only) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Consent and follow-up only) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
What NCT03351348 shows while recruiting
NCT03351348 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine is the first listed.
NCT03351348 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03351348 about?
NCT03351348 is a clinical study titled "Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control". 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 pai...
What is the current status of trial NCT03351348?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2017-11-16. Estimated completion is 2026-11.
What conditions does trial NCT03351348 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03351348?
The interventions under investigation include: Bupivacaine (DRUG), patient-reported pain scores (BEHAVIORAL), saline (OTHER).
Who is sponsoring clinical trial NCT03351348?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03351348 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03351348's enrollment target sits among peer trials
165 426th of 1224 higher than 797 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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