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NCT04872270
Pain Management After Shoulder Arthroplasty
Phase 3 trial testing Total Shoulder Arthroplasty in Caffeine in 160 participants. Status unknown.
15 April 2022
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 15 April 2021 |
| Primary completion | 15 April 2022 |
| Estimated completion | 15 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Total Shoulder Arthroplasty
- Caffeine Pill — full drug profile →
- Percocet 10Mg-325Mg Tablet — full drug profile →
- Zofran 4Mg Tablet — full drug profile →
Conditions studied
- Caffeine — all drugs for Caffeine →
- Pain, Joint — all drugs for Pain, Joint →
Sponsor
Rothman Institute Orthopaedics
Who can join
55 and older, any sex, with Caffeine or Pain, Joint. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04872270
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Caffeine
Currently open trials in the same condition.
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- NCT07404254 — Effects of Variations in Caffeinated Beverages on Well-being · NA · recruiting
- NCT06763172 — Effects of Caffeine on Reinforcement Learning in Healthy Adults Using PET/MRI · Phase 4 · recruiting
- NCT05325502 — Does Caffeine Facilitate Human Reward Learning Behaviors? · NA · active not recruiting
- NCT05454332 — The Caffeine Therapy in the Fetal to Neonatal Transition · Phase 4 · recruiting
Other Rothman Institute Orthopaedics trials
Trials by the same sponsor.
- NCT06903767 — Automated V Manual Impactor Study · NA · enrolling by invitation
- NCT06601803 — Surgiphor Us in TSA · Phase 4 · enrolling by invitation
- NCT06575010 — Exparel v Dexamethasone in RCR · Phase 4 · enrolling by invitation
- NCT06536842 — Wound Drain After Lumbar Fusion Surgery · NA · enrolling by invitation
- NCT06484192 — Pain Control After Lumbar Spine Fusion · Phase 4 · enrolling by invitation
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 NCT04872270 (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 Rothman Institute Orthopaedics
- Last refreshed: 4 May 2021
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/NCT04872270.
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