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Analgesic Techniques for Rib Fractures

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2025 to Aug 31, 2025
    • Study completion date: Aug 2025 to Dec 1, 2025
    • Start date: Sep 1, 2024 to Sep 23, 2024
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 2025 to Jul 2025
    • Start date changed from estimate of Aug 2024 to Sep 1, 2024
    • Site details revised
    v4
  3. Notable Phase: Not applicable to Phase 4
    • Study sites: 0 to 1
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids. Our specific aims are: 1. To compare the opioid use and pain ratings over the first 72 hours after enrollment. 2. To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention. 3. To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory). Inclusion Criteria: • Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital. Exclusion Criteria: * Allergy to amide local anesthetics, lidocaine, or ropivacaine * Pregnancy * Bilateral rib fractures * Coagulopathy (INR \> 1.5; PTT \> 1.5 times ULN, or platelets \< 75,000) * Conduction block on EKG * Total body weight \< 40 kg * Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen * Spine fracture at the level of intended ESP block * Infection near the ESP insertion site or active bacteremia or sepsis * Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded
Trial Details
NCT Number NCT06519929
Lead Sponsor Thomas Jefferson University
Conditions
(from sponsor)
Rib Fractures
Related terms Rib Fractures
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov