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Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery

Primary Purpose

Femur Fracture, Erector Spinae, Lumbar Plexus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESP block
LP block
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: undergoing proximal femoral surgery All patients who can respond to pain assessment questions Exclusion Criteria: With regional block contraindications, with severe cardiac and respiratory disease, with severe coagulopathy, having a body mass index greater than 35 patients will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ESP Block

    LP block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Postoperative opioid consumption
    Erector spina plan block is expected to provide effective postoperative analgesia and reduce postoperative intravenous opioid consumption in patients undergoing hip surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    April 17, 2023
    Sponsor
    Sakarya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05817916
    Brief Title
    Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery
    Official Title
    Comparison of Erector Spina Plane Block and Lumbar Plexus Block for Postoperative Analgesia in Femoral Fracture Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 15, 2023 (Anticipated)
    Primary Completion Date
    April 15, 2024 (Anticipated)
    Study Completion Date
    August 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sakarya University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femur Fracture, Erector Spinae, Lumbar Plexus, Ultrasound Guide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1: The patients in the first group (ESP Group) will be applied ultrasound guided ESP block at the lateral position at the end of the surgery. ESP will be performed with a posterior approach, under ultrasound guidance, by imaging the muscles and the needle. Group 2: At the end of the surgery, patients in the second group (LP Group) will have an appropriate level of LP block with ultrasound guidance and, if necessary, using a neurostimulator.
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESP Block
    Arm Type
    Active Comparator
    Arm Title
    LP block
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    ESP block
    Intervention Description
    ESP block: ultrasound guided erector spina plane block
    Intervention Type
    Procedure
    Intervention Name(s)
    LP block
    Intervention Description
    LP block: ultrasound guided lumbar plexus block
    Primary Outcome Measure Information:
    Title
    Postoperative opioid consumption
    Description
    Erector spina plan block is expected to provide effective postoperative analgesia and reduce postoperative intravenous opioid consumption in patients undergoing hip surgery.
    Time Frame
    postoperative 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: undergoing proximal femoral surgery All patients who can respond to pain assessment questions Exclusion Criteria: With regional block contraindications, with severe cardiac and respiratory disease, with severe coagulopathy, having a body mass index greater than 35 patients will be excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29860224
    Citation
    Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.
    Results Reference
    result
    PubMed Identifier
    29522966
    Citation
    Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
    Results Reference
    result

    Learn more about this trial

    Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery

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