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Post-Op Pain Control for Prophylactic Intramedullary Nailing.

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Oct 31, 2026 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Mar 31, 2027
    v11
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Aug 1, 2024 to Oct 31, 2026
    • Study completion date: Oct 1, 2024 to Dec 31, 2026
    v9
  4. Eligibility criteria expanded, about 8 words
    • Site contact updated
    v8
  5. Site contact updatedv7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Aug 1, 2023 to Aug 1, 2024
    • Study completion date: Oct 1, 2023 to Oct 1, 2024
    v6
  2. Primary completion date: Aug 1, 2021 to Aug 1, 2023
    • Study completion date: Oct 1, 2021 to Oct 1, 2023
    v5
  3. Primary completion date: Aug 1, 2020 to Aug 1, 2021
    • Study completion date: Oct 1, 2020 to Oct 1, 2021
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 15, 2019 to Feb 20, 2019
    v3
  5. Start date: Feb 1, 2019 to Mar 15, 2019
    • Primary completion date: Jul 1, 2020 to Aug 1, 2020
    • Study completion date: Aug 1, 2020 to Oct 1, 2020
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.
Trial Details
NCT Number NCT03823534
Lead Sponsor St. Louis University
Conditions
(from sponsor)		 Bone Metastases, Lymphoma, Multiple Myeloma, Opioid Use, Pain
Related terms Lymphoma, Multiple Myeloma, Pain, Postoperative Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov