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NCT04908449 · ClinicalTrials.gov registry record · Phase 1
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT04908449: Completed Phase 1 study, sponsored by Medical College of Wisconsin.
NCT04908449 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04908449, a Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
Primary Outcome
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Interventions
- DRUG Rectus sheath block with bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2023-06-19 |
| Est. Completion | 2024-11-14 |
| Phase | Phase 1 |
What the finished NCT04908449 record still lists
NCT04908449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Rectus sheath block with bupivacaine is the first listed.
NCT04908449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04908449 about?
NCT04908449 is a clinical study titled "Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery". The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from electi...
What is the current status of trial NCT04908449?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2023-06-19. Estimated completion is 2024-11-14.
What interventions are being tested in trial NCT04908449?
The interventions under investigation include: Rectus sheath block with bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04908449?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04908449's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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