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PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pericapsular nerve Group block
Facia Iliaca block
Fentanyl
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring PENG block, Hip fracture, analgesia, Fascia Iliaca block, ultrasound, Fentanyl

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient acceptance.
  2. Accepted mental state of the patient.
  3. Gender: both sexes.
  4. Age above 65 years old.
  5. Body mass index 18.5-35 kg/m2.
  6. ASA physical status II and III.
  7. Unilateral hip fracture assigned for surgical fixation.
  8. Expected duration of surgery ≤ 3 hours.

Exclusion Criteria:

  1. Associated trauma or multiple fractures.
  2. Peripheral neuropathy.
  3. Coagulopathy.
  4. Infection at site of injection.
  5. Allergy to the drugs used in the study.
  6. Advanced kidney, liver or heart disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Group C

    Group P

    Group F

    Arm Description

    Patients will be assigned to receive opioids analgesia before spinal anesthesia in the form of intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between before positioning the patient for spinal anesthesia.

    Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.

    Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.

    Outcomes

    Primary Outcome Measures

    Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.
    Analysis of Visual Analogue Pain Score for both PENG block and FI block before and after each block during rest and movement to compare between their analgesic effect. The Visual Analogue Pain score is done by drawing a 10cm vertical line on a piece of paper with its limits "no pain" (0) on one side and "extreme pain" (10) on the other side. The patient will be asked to point where the pain (he/she) experiences lies on the line.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2020
    Last Updated
    September 27, 2020
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04564326
    Brief Title
    PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture
    Official Title
    Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    September 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.
    Detailed Description
    Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results. In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fractures
    Keywords
    PENG block, Hip fracture, analgesia, Fascia Iliaca block, ultrasound, Fentanyl

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Patients will be assigned to receive opioids analgesia before spinal anesthesia in the form of intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between before positioning the patient for spinal anesthesia.
    Arm Title
    Group P
    Arm Type
    Experimental
    Arm Description
    Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.
    Arm Title
    Group F
    Arm Type
    Experimental
    Arm Description
    Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pericapsular nerve Group block
    Other Intervention Name(s)
    PENG block
    Intervention Description
    Under ultrasound guidance a needle is inserted between the iliopectineal eminence and the iliopsoas muscle and tendon to block articular branches supplying the capsule of hip joint.
    Intervention Type
    Procedure
    Intervention Name(s)
    Facia Iliaca block
    Other Intervention Name(s)
    FI block
    Intervention Description
    Under ultrasound guidance a needle is inserted between the fascia iliaca and Psoas muscle to block the femoral, obturator and lateral cutaneous nerves.
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Other Intervention Name(s)
    Intravenous opioid
    Intervention Description
    Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.
    Primary Outcome Measure Information:
    Title
    Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.
    Description
    Analysis of Visual Analogue Pain Score for both PENG block and FI block before and after each block during rest and movement to compare between their analgesic effect. The Visual Analogue Pain score is done by drawing a 10cm vertical line on a piece of paper with its limits "no pain" (0) on one side and "extreme pain" (10) on the other side. The patient will be asked to point where the pain (he/she) experiences lies on the line.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient acceptance. Accepted mental state of the patient. Gender: both sexes. Age above 65 years old. Body mass index 18.5-35 kg/m2. ASA physical status II and III. Unilateral hip fracture assigned for surgical fixation. Expected duration of surgery ≤ 3 hours. Exclusion Criteria: Associated trauma or multiple fractures. Peripheral neuropathy. Coagulopathy. Infection at site of injection. Allergy to the drugs used in the study. Advanced kidney, liver or heart disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    khaled M Mohamed, Master degree
    Phone
    00201007575373
    Email
    dr_k3@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khaled M Mohamed, Master degree
    Organizational Affiliation
    Zagazig University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16809710
    Citation
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    Links:
    URL
    http://www.hqontario.ca/evidence/publications-and-ohtac-recommendations/clinical-handbooks
    Description
    Quality-Based Procedures: Clinical Handbook for Hip Fracture.

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    PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

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