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NCT05642416
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
Phase 4 trial testing Continuous Infusion of ropivacaine in Post Operative Pain in 240 participants. Completed in 23 December 2024.
23 December 2024
Quick facts
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 15 October 2022 |
| Primary completion | 23 December 2024 |
| Estimated completion | 23 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Continuous Infusion of ropivacaine — full drug profile →
- Intermittent bolus of ropivacaine — full drug profile →
Conditions studied
- Post Operative Pain — all drugs for Post Operative Pain →
Sponsor
Henry Ford Health System — full company profile →
Who can join
Adults 18 to 90, any sex, with Post Operative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05642416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Post Operative Pain
Currently open trials in the same condition.
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- NCT07227064 — Methadone in THA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
- NCT07226076 — Methadone in TKA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
- NCT07349810 — Post Operative Infusion Pump Pain Study · Phase 4 · recruiting
Other Henry Ford Health System trials
Trials by the same sponsor.
- NCT07450183 — Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 · Phase 2 · not yet recruiting
- NCT07418853 — Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries · NA · not yet recruiting
- NCT06670287 — The Use of Multiple Sensors to Track Sleep in Nightshift Workers · NA · recruiting
- NCT07363525 — Michigan Initial Experience Using Tigertriever for Thrombectomy · not yet recruiting
- NCT07530172 — Radioembolization Versus External Radiation Therapy · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05642416 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
- Last refreshed: 11 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05642416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing