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NCT03090152 · ClinicalTrials.gov registry record · Phase 4
Minimal Opioid Use After Total Hip Replacement (THR)
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT03090152 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 180 participants.
The verdict
NCT03090152, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study Summary
Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more favorable pain profile with ambulation, but greater side effects compared to injection of a peri-articular cocktail. The use of opioid was greater in the peri-articular injection group (PAI). There was no difference in length of stay. In view of the controversy over opioid use, the investigators would like to develop an optimal opioid sparing pain management approach by comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain control while minimizing opioid use and side-effects.
Interventions
- DRUG Placebo
- DRUG Bupivacaine
- PROCEDURE Periarticular injection (Deep injection)
- PROCEDURE Periarticular injection (Superficial injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2019-09-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03090152
The ClinicalTrials.gov registry entry for NCT03090152 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03090152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03090152 about?
NCT03090152 is a clinical study titled "Minimal Opioid Use After Total Hip Replacement (THR)". Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (...
What is the current status of trial NCT03090152?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2017-03-08. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT03090152?
The interventions under investigation include: Placebo (DRUG), Bupivacaine (DRUG), Periarticular injection (Deep injection) (PROCEDURE), Periarticular injection (Superficial injection) (PROCEDURE).
Who is sponsoring clinical trial NCT03090152?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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