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NCT03845881 · ClinicalTrials.gov registry record · Early Phase 1
Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
A Early Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
NCT03845881: Completed Early Phase 1 study, sponsored by Mayo Clinic.
NCT03845881 is a Early Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 45 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845881, a Early Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
To help curb the use of opioid medications following orthopedic surgery investigators have developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and without the inclusion of opioid medications. This study will be performed in a randomized, double-blinded, placebo-controlled fashion in patients undergoing primary total knee or total hip arthroplasty. Investigators hypothesize that the opioid devoid pathway will show equivalent pain scores to the pathway that includes opioids while also having less constipation, nausea, and vomiting following surgery. If successful, this would create a dramatic decrease in opioid consumption following orthopedic surgery while still providing appropriate pain relief to patients.
Primary Outcome
compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group. This will be performed with clinical exams while in the hospital and with phone surveys on discharge. Results will be recorded using the Visual Analog Scale for pain scores. This scale ranges from 0 to 10, with zero being no pain and 10 being as bad as can be, and includes visual facial cu
Interventions
- DRUG Oxycodone
- DRUG Placebo Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2020-07-28 |
| Phase | Early Phase 1 |
What the finished NCT03845881 record still lists
NCT03845881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxycodone is the first listed.
NCT03845881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03845881 about?
NCT03845881 is a clinical study titled "Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty". To help curb the use of opioid medications following orthopedic surgery investigators have developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and without the inclusion of opioid medications. This study will be performed in a randomized, double-blinded, placebo-c...
What is the current status of trial NCT03845881?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2019-04-10. Estimated completion is 2020-07-28.
What interventions are being tested in trial NCT03845881?
The interventions under investigation include: Oxycodone (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03845881?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03845881's enrollment target sits among peer trials
45 575th of 2000 higher than 1,413 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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