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NCT03187080 · ClinicalTrials.gov registry record · Phase 4
Enhanced Recovery Strategies in Elective Breast Surgery
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 4
- Development phase
- 113
- Enrollment target
NCT03187080: Clinical Trial Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT03187080 is a Phase 4 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 113 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187080, a Phase 4 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 113 participants
- Enrollment target
Study Summary
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide. The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. The investigators will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.
Primary Outcome
Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.
Interventions
- PROCEDURE Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
- OTHER Enhanced recovery after breast surgery (ERABS) strategies
- PROCEDURE Sham paravertebral block using saline
- DRUG Paravertebral block using local anesthetic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 4 |
Why NCT03187080 stopped before completion
NCT03187080 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline is the first listed.
NCT03187080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03187080 about?
NCT03187080 is a clinical study titled "Enhanced Recovery Strategies in Elective Breast Surgery". Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical c...
What is the current status of trial NCT03187080?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 113 participants. The study started on 2017-10-19. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT03187080?
The interventions under investigation include: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (PROCEDURE), Enhanced recovery after breast surgery (ERABS) strategies (OTHER), Sham paravertebral block using saline (PROCEDURE), Paravertebral block using local anesthetic (DRUG).
Who is sponsoring clinical trial NCT03187080?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03187080's enrollment target sits among peer trials
113 723rd of 2000 higher than 1,277 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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