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NCT03360214 · ClinicalTrials.gov registry record · Phase 4
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03360214: Completed Phase 4 study, sponsored by Columbia University.
NCT03360214 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03360214, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control. This study has the interdisciplinary cooperation of the regional anesthesia group, and the breast and plastic surgery divisions. All female patients with breast cancer evaluated at Columbia University Medical Center (CUMC) who are undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be offered enrollment in this prospective study.
Primary Outcome
Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Interventions
- OTHER Placebo Drug
- DRUG Bupivacaine Hydrochloride
- DEVICE Pulsed Electromagnetic Field (PEMF) Device
- OTHER Placebo Device
- DRUG Ropivacaine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2022-03-07 |
| Phase | Phase 4 |
What the finished NCT03360214 record still lists
NCT03360214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo Drug is the first listed.
NCT03360214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03360214 about?
NCT03360214 is a clinical study titled "PEMF and PEC Blocks in Mastectomy Reconstruction Patients". This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control. This study has the interdisciplinary cooperation of the regional anesthesia ...
What is the current status of trial NCT03360214?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2017-07-05. Estimated completion is 2022-03-07.
What interventions are being tested in trial NCT03360214?
The interventions under investigation include: Placebo Drug (OTHER), Bupivacaine Hydrochloride (DRUG), Pulsed Electromagnetic Field (PEMF) Device (DEVICE), Placebo Device (OTHER), Ropivacaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03360214?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03360214's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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