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Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
unilateral intrathecal block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair

Exclusion Criteria:

  • uncooperative patient
  • Allergy to local anesthetic drugs
  • patients on chronic alcohol, opioid, tranquilizer or sedative use
  • Pregnant females.
  • Psychological, mental disorders, or depression.
  • Patients receiving anticoagulants therapy or suspected coagulopathy.
  • Patients with infection or previous surgery at sit of anesthetic procedures.
  • Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    intrathecal block

    Quadratus lumborum block

    Arm Description

    patients (25) will receive unilateral intrathecal block using 1.5 ml of hyperbaric bupivacaine

    patients (25) will receive quadratus lumborum block by an anterior approach using 30 ml of bupivacaine 0.25%

    Outcomes

    Primary Outcome Measures

    To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block
    complications of the block in each group like inadequate blockade detected by increased dose of sedation required in this group ,hemodynamic instability related to the block detected by frequent monitoring of the blood pressure and heart rate

    Secondary Outcome Measures

    To compare the onset and duration of sensory block between both blocks
    the onset of pin brick discrimination and time of first request of analgesics after block performance in each group
    To compare the time to ambulation
    the time till the patient succeed in ambulation

    Full Information

    First Posted
    March 15, 2021
    Last Updated
    April 5, 2021
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04805580
    Brief Title
    Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair
    Official Title
    Ultrasound Guided Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Patient Undergoing Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 2021 (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

    5. Study Description

    Brief Summary
    compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.
    Detailed Description
    comparison between unilateral intrathecal block anesthesia (unilateral SA) and Quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. Limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events. Previous case report studies stated that we can use Quadratus Lumborum Block as the sole anesthetic technique for open hernia repair.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 groups (25 in each group) group intrathecal block group quadratus lumborum block
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intrathecal block
    Arm Type
    Active Comparator
    Arm Description
    patients (25) will receive unilateral intrathecal block using 1.5 ml of hyperbaric bupivacaine
    Arm Title
    Quadratus lumborum block
    Arm Type
    Active Comparator
    Arm Description
    patients (25) will receive quadratus lumborum block by an anterior approach using 30 ml of bupivacaine 0.25%
    Intervention Type
    Procedure
    Intervention Name(s)
    unilateral intrathecal block
    Other Intervention Name(s)
    unilateral spinal anaesthesia
    Intervention Description
    Quadratus lunborum block
    Primary Outcome Measure Information:
    Title
    To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block
    Description
    complications of the block in each group like inadequate blockade detected by increased dose of sedation required in this group ,hemodynamic instability related to the block detected by frequent monitoring of the blood pressure and heart rate
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    To compare the onset and duration of sensory block between both blocks
    Description
    the onset of pin brick discrimination and time of first request of analgesics after block performance in each group
    Time Frame
    12 hours
    Title
    To compare the time to ambulation
    Description
    the time till the patient succeed in ambulation
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair Exclusion Criteria: uncooperative patient Allergy to local anesthetic drugs patients on chronic alcohol, opioid, tranquilizer or sedative use Pregnant females. Psychological, mental disorders, or depression. Patients receiving anticoagulants therapy or suspected coagulopathy. Patients with infection or previous surgery at sit of anesthetic procedures. Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hala Rashad
    Phone
    +201148737769
    Email
    rashad_hala@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa El-Deen=
    Phone
    +21271550089
    Email
    asmaa_galal79@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    1 year
    Citations:
    PubMed Identifier
    32444629
    Citation
    Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
    Results Reference
    background
    PubMed Identifier
    30050698
    Citation
    La Colla L, La Colla MDL, Schroeder R, Schroeder RMD. Quadratus Lumborum Block as Sole, Homeostatic-Preserving Anesthetic for a Patient with Multiple System Atrophy Undergoing Open Inguinal Hernia Repair: A Case Report. Case Rep Anesthesiol. 2018 Jun 28;2018:7161860. doi: 10.1155/2018/7161860. eCollection 2018. Erratum In: Case Rep Anesthesiol. 2018 Aug 19;2018:8316750. La Colla MDL [corrected to La Colla L], Schroeder RMD [corrected to Schroeder R].
    Results Reference
    background
    PubMed Identifier
    27366432
    Citation
    Isil CT, Cinar AS, Oba S, Isil RG. Comparison of Spinal Anaesthesia and Paravertebral Block in Unilateral Inguinal Hernia Repair. Turk J Anaesthesiol Reanim. 2014 Oct;42(5):257-63. doi: 10.5152/TJAR.2014.75508. Epub 2014 Jul 9.
    Results Reference
    background

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    Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair

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