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Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department

Primary Purpose

Hip Fractures, Pain, Acute, Ultrasound Therapy; Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fractures Pain Ultrasound nerve block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low energy Hip Fracture

Exclusion Criteria:

  • Don´t meet Inclusion Criteria
  • Present any other synchronic fracture.
  • Drug allergy for drugs used for nerve blocking
  • Skin infection at injection site.
  • Contraindication due to comorbidities.
  • Pathologic fractures.
  • Cognitive impairment
  • Do not give his consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    No Nerve Blocking

    Ultrasound Nerve blocking

    Arm Description

    Pain management at ER Department will be as usually with iv drugs and 3 kilogram soft traction.

    Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block.

    Outcomes

    Primary Outcome Measures

    Pain Control after Ultrasound guided nerve block vs iv painkillers
    Using Visual Analogue Scale (1-No pain; 10 -worst pain) measure difference between pain during arrival at Emergency Department and 30 minutes after Ultrasound guided nerve block vs iv painkillers

    Secondary Outcome Measures

    Patient Hip Mobility with tolerable pain
    Range of Motion Degrees
    Functionality: Sit to Stand Test
    The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds
    Opioid Use
    Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses
    Patient Satisfaction
    Patient subjective satisfaction in a numeric scale from 1 (completely dissatisfied with pain management) to 10 (highest possible satisfaction with pain management).

    Full Information

    First Posted
    February 25, 2022
    Last Updated
    June 1, 2022
    Sponsor
    Hospital San Carlos, Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05403073
    Brief Title
    Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
    Official Title
    Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital San Carlos, Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.
    Detailed Description
    Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today. Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use. This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fractures, Pain, Acute, Ultrasound Therapy; Complications
    Keywords
    Hip Fractures Pain Ultrasound nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No Nerve Blocking
    Arm Type
    No Intervention
    Arm Description
    Pain management at ER Department will be as usually with iv drugs and 3 kilogram soft traction.
    Arm Title
    Ultrasound Nerve blocking
    Arm Type
    Active Comparator
    Arm Description
    Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
    Intervention Description
    Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
    Primary Outcome Measure Information:
    Title
    Pain Control after Ultrasound guided nerve block vs iv painkillers
    Description
    Using Visual Analogue Scale (1-No pain; 10 -worst pain) measure difference between pain during arrival at Emergency Department and 30 minutes after Ultrasound guided nerve block vs iv painkillers
    Time Frame
    During Emergency Department stay (up to 12 hours)
    Secondary Outcome Measure Information:
    Title
    Patient Hip Mobility with tolerable pain
    Description
    Range of Motion Degrees
    Time Frame
    Immediately Before Discharging home assessed up to 2 weeks.
    Title
    Functionality: Sit to Stand Test
    Description
    The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds
    Time Frame
    Immediately Before Discharging home assessed up to 2 weeks.
    Title
    Opioid Use
    Description
    Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses
    Time Frame
    Immediately Before Discharging home assessed up to 2 weeks.
    Title
    Patient Satisfaction
    Description
    Patient subjective satisfaction in a numeric scale from 1 (completely dissatisfied with pain management) to 10 (highest possible satisfaction with pain management).
    Time Frame
    Immediately Before Discharging home assessed up to 2 weeks.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Low energy Hip Fracture Exclusion Criteria: Don´t meet Inclusion Criteria Present any other synchronic fracture. Drug allergy for drugs used for nerve blocking Skin infection at injection site. Contraindication due to comorbidities. Pathologic fractures. Cognitive impairment Do not give his consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Borja Alcobía-Díaz, MD, PhD
    Phone
    913303001
    Ext
    3638
    Email
    dralcobiacot@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Borja Alcobía-Díaz, MD, PhD
    Organizational Affiliation
    Clinical Assistant
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Email Contact

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    Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department

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