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NCT03845881
Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
EARLY_PHASE1 trial testing Oxycodone in Total Knee Arthroplasty in 45 participants. Completed in 28 July 2020.
28 July 2020
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 10 April 2019 |
| Primary completion | 28 July 2020 |
| Estimated completion | 28 July 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oxycodone (oxycodone) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
Sponsor
Mayo Clinic
Who can join
Adults 18 to 89, any sex, with Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Total Knee Arthroplasty With and Without Schedule II Opioids: A Randomized, Double-Blinded, Placebo-Controlled Trial.
Young PF, Roberts C, Shi GG, Heckman MG, et al · · 2024 · PMID 38618342 · DOI 10.7759/cureus.56150
Verify or expand the search:
- PubMed search for NCT03845881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxycodone
Trials testing the same drug.
- NCT07153003 — Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And · Phase 4 · enrolling by invitation
- NCT06757140 — Opioid Drug Interaction Study · Phase 1, PHASE2 · recruiting
- NCT05965492 — Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery · Phase 3 · withdrawn
- NCT06517069 — Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients · NA · recruiting
- NCT06340932 — Impact of Opioid Avoidance Protocol for ACL Reconstruction · completed
Other recruiting trials for Total Knee Arthroplasty
Currently open trials in the same condition.
- NCT07524387 — Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty · NA · recruiting
- NCT07511842 — REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes · NA · recruiting
- NCT07324954 — Methylene Blue in Total Knee Arthroplasty (TKA) · Phase 1 · recruiting
- NCT07336160 — ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty · NA · recruiting
- NCT07371390 — Minimal Sedation During Knee Replacement Surgery · NA · recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
- NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
- NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
- NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
- NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
- NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet 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 NCT03845881 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 30 July 2020
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/NCT03845881.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing