RECRUITING
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Peripheral Nerve Blocks for Above-the-knee Amputations
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
Conditions:
🦠 Peripheral Vascular Diseases 🦠 Hyperglycaemia (Diabetic) 🦠 Hypertension 🦠 Coronary Artery Disease 🦠 Pulmonary Disease, Chronic Obstructive
🗓️ Study Start (Actual) 9 February 2018
🗓️ Primary Completion (Estimated) 4 August 2024
✅ Study Completion (Estimated) 4 August 2024
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients undergoing above-the-knee amputation or knee disarticulation
    • * Ability to understand and provide informed consent

    Exclusion Criteria:

    • * Patient refusal or inability to provide informed consent
    • * True allergy, not sensitivity, to any of the following substances:
    • * - Local anesthetics
    • * - Propofol or other sedative agents
    • * - General anesthetic agents
    • * Pregnancy
    • * Severe hepatic impairment
    • * Evidence of infection at or near the proposed needle insertion site
    • * Any sensorimotor deficit, whether acute or chronic, as determined by the PI
    • * Chronic use of opioid medication
    • * BMI ≥ 35
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 December 2017
  • First Submitted that Met QC Criteria 11 January 2018
  • First Posted 19 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 September 2023
  • Last Update Posted 15 September 2023
  • Last Verified September 2023
I'm interested ...!!