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NCT05642416 · ClinicalTrials.gov registry record · Phase 4
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
A Phase 4 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
NCT05642416 is a Phase 4 study that has completed, run by Henry Ford Health System. The registered enrollment target is 240 participants.
The verdict
NCT05642416, a Phase 4 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
Study Summary
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
Interventions
- DRUG Continuous Infusion of ropivacaine
- DRUG Intermittent bolus of ropivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-10-18 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05642416
The ClinicalTrials.gov registry entry for NCT05642416 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Continuous Infusion of ropivacaine is the first listed.
NCT05642416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05642416 about?
NCT05642416 is a clinical study titled "Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT". The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters....
What is the current status of trial NCT05642416?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2022-10-18. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT05642416?
The interventions under investigation include: Continuous Infusion of ropivacaine (DRUG), Intermittent bolus of ropivacaine (DRUG).
Who is sponsoring clinical trial NCT05642416?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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