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NCT02044302 · ClinicalTrials.gov registry record · Phase 2
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02044302: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT02044302 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02044302, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.
Primary Outcome
The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.
Interventions
- DRUG Bupivacaine
- DRUG Botulinum Toxins
- DRUG Analgesics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
Why NCT02044302 stopped before completion
NCT02044302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.
NCT02044302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02044302 about?
NCT02044302 is a clinical study titled "A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction". The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid a...
What is the current status of trial NCT02044302?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2014-04. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02044302?
The interventions under investigation include: Bupivacaine (DRUG), Botulinum Toxins (DRUG), Analgesics (DRUG).
Who is sponsoring clinical trial NCT02044302?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02044302's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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