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NCT05676814 · ClinicalTrials.gov registry record · Phase 4
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
A Phase 4 study of Analgesia and Sternotomy, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT05676814: Completed Phase 4 study of Analgesia and Sternotomy, sponsored by Wake Forest University Health Sciences.
NCT05676814 is a Phase 4 study of Analgesia and Sternotomy that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 31 participants, below the 91-participant average among 19 other Analgesia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05676814, a Phase 4 study of Analgesia and Sternotomy, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
Primary Outcome
Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
Conditions Studied
Interventions
- DRUG Pecto-intercostal Fascial Block (PIFB)
- DRUG PIFB with adjuvants
Study Locations (1)
North Carolina
- Wake Forest Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-03-24 |
| Est. Completion | 2023-06-24 |
| Phase | Phase 4 |
What the finished NCT05676814 record still lists
NCT05676814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 91-participant average among 19 other Analgesia trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Analgesia appearing as the primary indexed condition, and to 2 interventions - of which Pecto-intercostal Fascial Block (PIFB) is the first listed.
NCT05676814 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05676814 about?
NCT05676814 is a clinical study titled "Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients". The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving s...
What is the current status of trial NCT05676814?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2023-03-24. Estimated completion is 2023-06-24.
What conditions does trial NCT05676814 study?
This clinical trial studies the following conditions: Analgesia, Sternotomy.
What interventions are being tested in trial NCT05676814?
The interventions under investigation include: Pecto-intercostal Fascial Block (PIFB) (DRUG), PIFB with adjuvants (DRUG).
Who is sponsoring clinical trial NCT05676814?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05676814 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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