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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 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044302
The ClinicalTrials.gov registry entry for NCT02044302 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.
NCT02044302 reports 0 study locations.
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.
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