Last reviewed · How we verify
NCT03540030
Opioid-Free Shoulder Arthroplasty
Phase 4 trial testing Gabapentin in Opioid Use in 86 participants. Completed in 1 June 2019.
1 March 2019
Quick facts
| Lead sponsor | OrthoCarolina Research Institute, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 86 |
| Start date | 1 September 2016 |
| Primary completion | 1 March 2019 |
| Estimated completion | 1 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
- Celecoxib (celecoxib) — full drug profile →
- toradol (KETOROLAC) — full drug profile →
- acetaminophen
- regional block
- propofol
- IV lidocaine
- rocuronium (ROCURONIUM) — full drug profile →
- vecuronium
- sevoflurane — full drug profile →
- desflurane
Conditions studied
- Opioid Use — all drugs for Opioid Use →
- Shoulder Osteoarthritis — all drugs for Shoulder Osteoarthritis →
- Avascular Necrosis — all drugs for Avascular Necrosis →
- Rotator Cuff Tear — all drugs for Rotator Cuff Tear →
Sponsor
OrthoCarolina Research Institute, Inc.
Who can join
50 and older, any sex, with Opioid Use or Shoulder Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Post Op Pain
Time frame: 24 hours
Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)
Sponsor's own description
Purpose of Study: To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8
Verify or expand the search:
- PubMed search for NCT03540030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gabapentin
Trials testing the same drug.
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- NCT07131527 — Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy · NA · recruiting
- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Opioid Use
Currently open trials in the same condition.
- NCT07342504 — Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist · NA · recruiting
- NCT07004686 — Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients · NA · recruiting
- NCT06981195 — Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects · Phase 2 · recruiting
- NCT06806163 — Machine-Learning Prediction and Reducing Overdoses With EHR Nudges · NA · recruiting
- NCT06909851 — Comparison of Pain Relief After Arthroscopic Knee Surgery: Adductor Canal Block and Genicular Nerve Block · NA · recruiting
Other OrthoCarolina Research Institute, Inc. trials
Trials by the same sponsor.
- NCT07524465 — Mochida ReFeel for Digital Nerve Injuries · Phase 4 · not yet recruiting
- NCT06956508 — Prophylactic TBR on Phantom Limb Pain · NA · enrolling by invitation
- NCT06935331 — Prospective Opioid-Free AIS Fusion · Phase 4 · enrolling by invitation
- NCT06580899 — Intra-Articular Catheter Total Knee Arthroplasty · Phase 4 · enrolling by invitation
- NCT05931627 — Tourniquet Use in Anterior Cruciate Ligament Repair · NA · 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 NCT03540030 (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 OrthoCarolina Research Institute, Inc.
- Last refreshed: 9 October 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/NCT03540030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing