Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Primary and study completion dates: Aug 31, 2025 to Aug 31, 2026v19
  3. 2 versions Re-verified since Jan 14, 2025, no change to tracked fieldsv17-v18
  4. Study completion date: Oct 31, 2025 to Aug 31, 2025v16
  5. Primary completion date: Aug 31, 2023 to Aug 31, 2025
    • Study completion date: Oct 31, 2023 to Oct 31, 2025
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Aug 31, 2022 to Aug 31, 2023
    • Study completion date: Oct 31, 2022 to Oct 31, 2023
    v14
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2022 to Oct 12, 2021
    • Site details revised
    v13
  3. Primary completion date: Oct 31, 2021 to Aug 31, 2022v12 Show 4 more changesShow less
    • Start date: Aug 1, 2021 to Feb 1, 2022
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Oct 31, 2021 to Oct 31, 2022
    • Site details revised
  4. Start date: Apr 5, 2021 to Aug 1, 2021
    • Primary completion date: Jul 31, 2021 to Oct 31, 2021
    • Study completion date: Aug 31, 2021 to Oct 31, 2021
    v11
  5. Phase: Phase 4 to Not specifiedv10 Show 7 more changesShow less
    • Enrollment target: 40 to 60
    • Start date: Oct 22, 2020 to Apr 5, 2021
    • Primary completion date: Aug 1, 2021 to Jul 31, 2021
    • Study completion date: Aug 2, 2021 to Aug 31, 2021
    • Interventions: Bupivacaine (Drug), Ropivacaine (Drug), Ultrasound (Diagnostic Test) to Bupivacaine (Drug), MediPines AGM100 Advanced Respiratory Monitoring System (Device), Ropivacaine (Drug), Ultrasound (Diagnostic Test)
    • Study description expanded, about 21 words
    • Study arms: 2 to 3
  6. Primary completion date: Dec 31, 2020 to Aug 1, 2021
    • Study completion date: Jan 1, 2021 to Aug 2, 2021
    v9
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 15, 2020 to Oct 22, 2020
    • Site details revised
    v8
  8. Start date: Aug 15, 2020 to Oct 15, 2020
    • Primary completion date: Oct 30, 2020 to Dec 31, 2020
    • Study completion date: Dec 1, 2020 to Jan 1, 2021
    v7
  9. Start date: Jun 20, 2020 to Aug 15, 2020
    • Primary completion date: Sep 30, 2020 to Oct 30, 2020
    • Study completion date: Oct 1, 2020 to Dec 1, 2020
    v6
  10. Start date: May 15, 2020 to Jun 20, 2020
    • Primary completion date: May 15, 2021 to Sep 30, 2020
    • Study completion date: May 15, 2021 to Oct 1, 2020
    v5
  11. Start date: Mar 1, 2020 to May 15, 2020
    • Primary and study completion dates: Mar 15, 2021 to May 15, 2021
    v4
  12. Start date: Jan 15, 2020 to Mar 1, 2020
    • Primary and study completion dates: Jan 15, 2021 to Mar 15, 2021
    v3
  13. Primary endpoint revised
    • Interventions: Bupivaccine (Drug), Ropivacaine (Drug), Ultrasound (Diagnostic Test) to Bupivacaine (Drug), Ropivacaine (Drug), Ultrasound (Diagnostic Test)
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 5 words
    v2
  1. Study First Submitted
  • 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.
Duke University
457 trials monitored
See 58 trials at risk
This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.
Trial Details
NCT Number NCT04209504
Lead Sponsor Duke University
Conditions
(from sponsor)		 Shoulder Surgery, Shoulder Pain, Shoulder Injuries, Shoulder Arthritis, Shoulder Disease, Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Arthropathy of Left Shoulder +2 more
Related terms Rotator Cuff Injuries, Shoulder Injuries, Shoulder Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov