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Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Primary Purpose

Tourniquets, Anesthesia, Conduction, Anesthetics, Local

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Femoral artery block
Sponsored by
Hospital da Luz, Portugal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tourniquets

Eligibility Criteria

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

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I to III Receiving cruciate ligament surgery with > 30 minutes of tourniquet Combined anesthesia (balanced general anesthesia and femoral nerve block) Exclusion Criteria: Nerve block contraindications (block site infection, allergic to local anesthetic) Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft) Tourniquet inflation time < 30 min Patient refusal Pregnant patients Patients with a active psychiatric disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Femoral artery block

    No intervention

    Arm Description

    An experienced Anesthesiologist will perform the femoral blocks, under ultrasound guidance with a linear probe and a 50mm (millimeters) or 80mm needle. No nerve stimulator will be used during the block. In both groups, femoral nerve block at the nerve sheath will be performed with 20mL (milliliters) 0.5% ropivacaine. In the interventional group, additionally to the previous block, the needle will be retracted and advanced to the antero-medial side of the femoral artery where 10mL 0.5% ropivacaine will be injected after negative aspiration.

    Outcomes

    Primary Outcome Measures

    Incidence of Tourniquet Hypertension (TH)
    Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet
    Systolic blood pressure 30 minutes after tourniquet inflation
    SBP at 30 minutes after tourniquet inflation
    Systolic blood pressure 45 minutes after tourniquet inflation
    SBP at 45 minutes after tourniquet inflation
    Systolic blood pressure 60 minutes after tourniquet inflation
    SBP at 60 minutes after tourniquet inflation
    Systolic blood pressure 75 minutes after tourniquet inflation
    SBP at 75 minutes after tourniquet inflation
    Systolic blood pressure 90 minutes after tourniquet inflation
    SBP at 90 minutes after tourniquet inflation
    Systolic blood pressure 115 minutes after tourniquet inflation
    SBP at 115 minutes after tourniquet inflation
    Systolic blood pressure 130 minutes after tourniquet inflation
    SBP at 130 minutes after tourniquet inflation
    Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
    MAP at 30 minutes after tourniquet inflation
    Mean arterial pressure 45 minutes after tourniquet inflation
    MAP at 45 minutes after tourniquet inflation
    Mean arterial pressure 60 minutes after tourniquet inflation
    MAP at 60 minutes after tourniquet inflation
    Mean arterial pressure 75 minutes after tourniquet inflation
    MAP at 75 minutes after tourniquet inflation
    Mean arterial pressure 90 minutes after tourniquet inflation
    MAP at 90 minutes after tourniquet inflation
    Mean arterial pressure 115 minutes after tourniquet inflation
    MAP at 115 minutes after tourniquet inflation
    Mean arterial pressure 130 minutes after tourniquet inflation
    MAP at 130 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 30 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 45 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 60 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 75 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 90 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 115 minutes after tourniquet inflation
    Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation
    Variation of SBP compared to baseline at 130 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 30 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 45 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 60 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 75 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 90 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 115 minutes after tourniquet inflation
    Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation
    Variation of MAP compared to baseline at 130 minutes after tourniquet inflation

    Secondary Outcome Measures

    Isosorbide dinitrate administered for TH
    mg of isosorbide dinitrate administered for TH
    Numerical verbal pain scores
    Numerical verbal pain scores (from 0 to 10, 10 meaning higher pain) assessed 1 hour after emergence of anesthesia in the post-operative care unit (PACU)
    Patient post-operative satisfaction
    Patient post-operative satisfaction with pain treatment measured 1 hour after emergence of anesthesia in the post-operative care unit using a 5-point Likert-scale, namely: 1 - very unsatisfied, 2 - unsatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied (with higher scores meaning a higher outcome)

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Hospital da Luz, Portugal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05954689
    Brief Title
    Femoral Artery Block for Reduction of Tourniquet Induced Hypertension
    Official Title
    Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2023 (Anticipated)
    Primary Completion Date
    February 29, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital da Luz, Portugal

    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
    A randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with > 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tourniquets, Anesthesia, Conduction, Anesthetics, Local, Hypertension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Femoral artery block
    Arm Type
    Experimental
    Arm Description
    An experienced Anesthesiologist will perform the femoral blocks, under ultrasound guidance with a linear probe and a 50mm (millimeters) or 80mm needle. No nerve stimulator will be used during the block. In both groups, femoral nerve block at the nerve sheath will be performed with 20mL (milliliters) 0.5% ropivacaine. In the interventional group, additionally to the previous block, the needle will be retracted and advanced to the antero-medial side of the femoral artery where 10mL 0.5% ropivacaine will be injected after negative aspiration.
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Femoral artery block
    Intervention Description
    Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.
    Primary Outcome Measure Information:
    Title
    Incidence of Tourniquet Hypertension (TH)
    Description
    Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet
    Time Frame
    Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)
    Title
    Systolic blood pressure 30 minutes after tourniquet inflation
    Description
    SBP at 30 minutes after tourniquet inflation
    Time Frame
    30 minutes after tourniquet inflation
    Title
    Systolic blood pressure 45 minutes after tourniquet inflation
    Description
    SBP at 45 minutes after tourniquet inflation
    Time Frame
    45 minutes after tourniquet inflation
    Title
    Systolic blood pressure 60 minutes after tourniquet inflation
    Description
    SBP at 60 minutes after tourniquet inflation
    Time Frame
    60 minutes after tourniquet inflation
    Title
    Systolic blood pressure 75 minutes after tourniquet inflation
    Description
    SBP at 75 minutes after tourniquet inflation
    Time Frame
    75 minutes after tourniquet inflation
    Title
    Systolic blood pressure 90 minutes after tourniquet inflation
    Description
    SBP at 90 minutes after tourniquet inflation
    Time Frame
    90 minutes after tourniquet inflation
    Title
    Systolic blood pressure 115 minutes after tourniquet inflation
    Description
    SBP at 115 minutes after tourniquet inflation
    Time Frame
    115 minutes after tourniquet inflation
    Title
    Systolic blood pressure 130 minutes after tourniquet inflation
    Description
    SBP at 130 minutes after tourniquet inflation
    Time Frame
    130 minutes after tourniquet inflation
    Title
    Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
    Description
    MAP at 30 minutes after tourniquet inflation
    Time Frame
    30 minutes after tourniquet inflation
    Title
    Mean arterial pressure 45 minutes after tourniquet inflation
    Description
    MAP at 45 minutes after tourniquet inflation
    Time Frame
    45 minutes after tourniquet inflation
    Title
    Mean arterial pressure 60 minutes after tourniquet inflation
    Description
    MAP at 60 minutes after tourniquet inflation
    Time Frame
    60 minutes after tourniquet inflation
    Title
    Mean arterial pressure 75 minutes after tourniquet inflation
    Description
    MAP at 75 minutes after tourniquet inflation
    Time Frame
    75 minutes after tourniquet inflation
    Title
    Mean arterial pressure 90 minutes after tourniquet inflation
    Description
    MAP at 90 minutes after tourniquet inflation
    Time Frame
    90 minutes after tourniquet inflation
    Title
    Mean arterial pressure 115 minutes after tourniquet inflation
    Description
    MAP at 115 minutes after tourniquet inflation
    Time Frame
    115 minutes after tourniquet inflation
    Title
    Mean arterial pressure 130 minutes after tourniquet inflation
    Description
    MAP at 130 minutes after tourniquet inflation
    Time Frame
    130 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 30 minutes after tourniquet inflation
    Time Frame
    30 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 45 minutes after tourniquet inflation
    Time Frame
    45 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 60 minutes after tourniquet inflation
    Time Frame
    60 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 75 minutes after tourniquet inflation
    Time Frame
    75 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 90 minutes after tourniquet inflation
    Time Frame
    90 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 115 minutes after tourniquet inflation
    Time Frame
    115 minutes after tourniquet inflation
    Title
    Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation
    Description
    Variation of SBP compared to baseline at 130 minutes after tourniquet inflation
    Time Frame
    130 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 30 minutes after tourniquet inflation
    Time Frame
    30 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 45 minutes after tourniquet inflation
    Time Frame
    45 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 60 minutes after tourniquet inflation
    Time Frame
    60 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 75 minutes after tourniquet inflation
    Time Frame
    75 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 90 minutes after tourniquet inflation
    Time Frame
    90 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 115 minutes after tourniquet inflation
    Time Frame
    115 minutes after tourniquet inflation
    Title
    Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation
    Description
    Variation of MAP compared to baseline at 130 minutes after tourniquet inflation
    Time Frame
    130 minutes after tourniquet inflation
    Secondary Outcome Measure Information:
    Title
    Isosorbide dinitrate administered for TH
    Description
    mg of isosorbide dinitrate administered for TH
    Time Frame
    Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )
    Title
    Numerical verbal pain scores
    Description
    Numerical verbal pain scores (from 0 to 10, 10 meaning higher pain) assessed 1 hour after emergence of anesthesia in the post-operative care unit (PACU)
    Time Frame
    Up to 2 hours after emergence from anesthesia
    Title
    Patient post-operative satisfaction
    Description
    Patient post-operative satisfaction with pain treatment measured 1 hour after emergence of anesthesia in the post-operative care unit using a 5-point Likert-scale, namely: 1 - very unsatisfied, 2 - unsatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied (with higher scores meaning a higher outcome)
    Time Frame
    Up to 2 hours after emergence from anesthesia

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I to III Receiving cruciate ligament surgery with > 30 minutes of tourniquet Combined anesthesia (balanced general anesthesia and femoral nerve block) Exclusion Criteria: Nerve block contraindications (block site infection, allergic to local anesthetic) Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft) Tourniquet inflation time < 30 min Patient refusal Pregnant patients Patients with a active psychiatric disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vasyl HDS Katerenchuk
    Phone
    +351932902978
    Email
    vasylktr@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Filipa Duarte
    Organizational Affiliation
    Hospital da Luz, Lisboa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33510583
    Citation
    Guo YX, Wang GY, Cheng WJ, Yan CZ, Zhao S, Li Z, Liu P, Wang XL. Activation of Opioid Receptors Attenuates Ischemia/Reperfusion Injury in Skeletal Muscle Induced by Tourniquet Placement. Mediators Inflamm. 2021 Jan 15;2021:6699499. doi: 10.1155/2021/6699499. eCollection 2021.
    Results Reference
    background
    PubMed Identifier
    36549034
    Citation
    Xu F, Wang X, Li Y, Gao F, Yin C, Yu J, Li W, Zhu L, Wang Q. Combined femoral artery block and femoral nerve block reduces thigh tourniquet-induced hypertension. J Clin Anesth. 2023 May;85:111039. doi: 10.1016/j.jclinane.2022.111039. Epub 2022 Dec 20.
    Results Reference
    background
    PubMed Identifier
    33431616
    Citation
    Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11.
    Results Reference
    background

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    Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

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