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Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Sternotomy

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: May 1, 2023 to Jun 3, 2023
  2. Minor Trial completed Show 5 more changesShow less
    • Final enrollment: 160 participants (planned 138)
    • Primary completion date changed from estimate of May 2027 to Dec 1, 2023
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised
  3. Notable Primary and study completion dates: May 2024 to May 2027
    • Study description revised
    • Study title revised
    v4
  4. Minor Secondary endpoints revised (5)v3
  5. Notable Primary completion date: May 2023 to May 2024v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .
Trial Details
NCT Number NCT05885230
Lead Sponsor Beni-Suef University
Conditions
(from sponsor)
Cardiac Surgery
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov