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ESP Block vs FIB in Patients Undergoing Hip Arthroplasty

Primary Purpose

Hip Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector spinae plain block
Fascia Iliaca block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Arthropathy focused on measuring Erector spinae block, Fascia iliaca block

Eligibility Criteria

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

Inclusion Criteria:

  • Age between 18 and 65 years
  • ASA grade I to II
  • Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty

Exclusion Criteria:

  • Patient refusal
  • Age below 18 or above 65 years.
  • ASA grade III to IV
  • Patients with known allergies to any of the drugs used.
  • Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies.
  • Patients receiving opioids for chronic analgesic therapy
  • Inability to comprehend visual analogue scale (VAS)
  • Infection at site of erector spinae or fascia iliaca block.
  • Body mass index >35 kg/m2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ESPB Group

    FIB Group

    Arm Description

    This group will receive ultrasound-guided erector spinae plane block and subarachnoid block.

    This group will receive supra-inguinal fascia iliaca block and subarachnoid block .

    Outcomes

    Primary Outcome Measures

    Total morphine requirements
    Amount of morphine required postoperatively

    Secondary Outcome Measures

    Visual analogue pain score
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
    Time to first postoperative analgesic request
    If the visual analogue scale (VAS) was 4 or more, a morphine increment (2 mg) will be added to maintain a resting VAS at <3 and the total 24-hours morphine consumption will be recorded.
    Quadriceps muscle power strength
    For motor block assessment, the patient knee will be fully flexed and the patient will be asked to extend it. The motor block will be classified as follows: grade 0; normal muscle power, grade 1; motor weakness, grade 2; complete motor paralysis

    Full Information

    First Posted
    August 10, 2021
    Last Updated
    August 19, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05015517
    Brief Title
    ESP Block vs FIB in Patients Undergoing Hip Arthroplasty
    Official Title
    Comparison of Ultrasound Guided Erector Spinae Block and Supra-inguinal Fascia Iliaca Block for Postoperative Analgesia in Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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 of this study is to compare between the analgesic efficacy of ESP block and FIB in patients undergoing hip arthroplasty.
    Detailed Description
    Hip arthroplasty surgery is usually associated with severe postoperative pain. Several modalities are usually used for postoperative analgesia in these patients, those include; intravenous analgesia, neuraxial analgesia and peripheral nerve blocks. Peripheral nerve blocks have several advantages such as; potent analgesia, lower motor impairment and minimal systemic complications. Lumbar plexus block and supra-inguinal fascia iliaca block (FIB) are the most commonly performed peripheral nerve blocks for hip surgeries. Fascia iliaca block is one of the most common techniques for pain control after hip surgeries; it can be regarded as an anterior approach of the lumbar plexus. It provides analgesia through spread of local anaesthetic to the femoral and lateral cutaneous femoral nerves. Ultrasound guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described in 2016 for acute and chronic thoracic pain management. It is a paraspinal fascial plane block that provides analgesia through injecting local anesthetic drugs to block the ventral and dorsal rami of spinal nerves in the paravertebral area. To the best of the investigators knowledge, the use of ESP block in hip surgery was only investigated in one study and few case reports. Therefore, further randomized controlled studies are needed to prove this hypothesis. This study aims to investigate the efficacy of ESP block in hip replacement compared to the supra-inguinal FIB. The investigators hypothesize that erector spinae block may provide better postoperative analgesia than fascia iliaca block, since erector spinae block provides analgesic cover for the entire lumbar plexus rather than just peripheral nerves provided by fasicia iliaca.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthropathy
    Keywords
    Erector spinae block, Fascia iliaca block

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    computer-generated sequence. Concealment will be achieved using opaque envelopes. All data will be collected blindly and the authors will perform the blocks without interference in data collection.
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESPB Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive ultrasound-guided erector spinae plane block and subarachnoid block.
    Arm Title
    FIB Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive supra-inguinal fascia iliaca block and subarachnoid block .
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector spinae plain block
    Intervention Description
    Patients will be placed in the lateral position.Ultrasonography will be performed by an experienced anesthetist.The 4th lumbar vertebral level will be determined using the conventional method (imaginary line between two iliac crests). The low frequency convex probe (2-5MHz) will then be placed at the mid-vertebral line in the sagittal plane. It will be shifted from the midline, 3.5-4 cm lateral to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-plane technique a 22G/80-mm block needle will be advanced until it reaches the transverse process. After negative aspiration, 0.5-1 ml of the prepared local anaesthetic solution (20 ml bupivacaine 0.5%, 10 ml lidocaine 2%) and 10 ml normal saline will be administered for hydrodissection to confirm correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when injecting local anesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    Fascia Iliaca block
    Intervention Description
    Patients will be placed in supine position. Ultrasonography will be performed by an experienced anesthetist using ultrasound device equipped with a low frequency (2-5 MHz) convex probe and an echogenic 21 G/ 10 cm needle will be used. The probe will be placed in the inguinal crease. Scan will be started laterally from the femoral artery and nerve in the inguinal crease to identify the Sartorius muscle. The muscle will then be traced until its origin at the anterior superior iliac spine is identified and the shadow of the bony of iliac crest & iliacus muscle will be seen. Injection will be performed at the plane deep to the fascia iliaca and above the lateral part of the iliacus muscle. After negative aspiration, the prepared local anaesthetic solution (15 ml bupivacaine 0.5%, 15 ml normal saline) will be injected incrementally, aspirating every 5 ml.
    Primary Outcome Measure Information:
    Title
    Total morphine requirements
    Description
    Amount of morphine required postoperatively
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Visual analogue pain score
    Description
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
    Time Frame
    at rest at 2, 4, 6, 12, 18, and 24 hours postoperatively
    Title
    Time to first postoperative analgesic request
    Description
    If the visual analogue scale (VAS) was 4 or more, a morphine increment (2 mg) will be added to maintain a resting VAS at <3 and the total 24-hours morphine consumption will be recorded.
    Time Frame
    24 hours postoperatively
    Title
    Quadriceps muscle power strength
    Description
    For motor block assessment, the patient knee will be fully flexed and the patient will be asked to extend it. The motor block will be classified as follows: grade 0; normal muscle power, grade 1; motor weakness, grade 2; complete motor paralysis
    Time Frame
    at 6, 12 and 24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 65 years ASA grade I to II Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty Exclusion Criteria: Patient refusal Age below 18 or above 65 years. ASA grade III to IV Patients with known allergies to any of the drugs used. Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies. Patients receiving opioids for chronic analgesic therapy Inability to comprehend visual analogue scale (VAS) Infection at site of erector spinae or fascia iliaca block. Body mass index >35 kg/m2
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed MA Moawad, Ass.lecturer
    Phone
    01098189096
    Ext
    +2
    Email
    ahmedmohammed621991@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sheren Refaat, A.Professor
    Phone
    01005607829
    Ext
    +2
    Email
    Sherin.refaat@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashraf RA Aswa, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://journals.lww.com/anesthesia-analgesia/fulltext/2002/06000/continuous_psoas_compartment_block_for.45.aspx
    Description
    Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation
    URL
    https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=+Nye+ZB%2C+Horn+JL%2C+Crittenden+W%2C+Abrahams+MS%2C+Aziz+MF.+Ambulatory+continuous+posterior+lumbar+plexus+blocks+following+hip+arthroscopy%3A+a+review+of+213+cases.%C2%A0J+Clin+Anesth.%C2%A02013+Jun%3B25%284%29%3A268-274.++Bullock+WM&btnG=#d=gs_qabs&u=%23p%3DCrp2CiuaHgMJ
    Description
    Abrahams MS, Aziz MF. Ambulatory continuous posterior lumbar plexus blocks following hip arthroscopy: a review of 213 cases
    URL
    https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Bullock+WM%2C%C2%A0Yalamuri+SM%2C%C2%A0Gregory+SH%2C%C2%A0Auyong+DB%2C%C2%A0Grant+SA%2C+Ultrasound-Guided+Suprainguinal+Fascia+Iliaca+Technique+Provides+Benefit+as+an+Analgesic+Adjunct+for+Patients+Undergoing+Total%C2%A0Hip%C2%A0Arthroplasty%2C+J+Ultrasound+Med.%2C+2017+Feb%3B36%282%29%3A433-438.&btnG=#d=gs_qabs&u=%23p%3DNHm8V774Mx0J
    Description
    Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty
    URL
    https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Desmet%C2%A0M%2C%C2%A0Vermeylen%C2%A0K%2C%C2%A0Van+Herreweghe%C2%A0I%2C+et+al.A+Longitudinal+Supra-Inguinal+Fascia+Iliaca+Compartment+Block+Reduces+Morphine+Consumption+After+Total+Hip+Arthroplasty.Regional+Anesthesia+%26Pain+Medicine%C2%A02017%3B42%3A327-333.&btnG=#d=gs_qabs&u=%23p%3D4cdBlf-qnskJ
    Description
    Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty
    URL
    https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=++Forero+M%2C+Adhikary+SD%2C+Lopez+H%2C+et+al.+The+erector+spinae+plane+block%3A+a+novel+analgesic+technique+in+thoracic+neuropathic+pain.+Reg+Anesth+Pain+Med.+2016%3B41%285%29%3A621%E2%80%93627.&btnG=#d=gs_qabs&u=%23p%3DFSUO-gw42YEJ
    Description
    The erector spinae plane block: a novel analgesic technique in thoracic neuropathic pain.
    URL
    https://search.proquest.com/openview/70d234ac1634867694810005281fe12a/1?pq-origsite=gscholar&cbl=226517
    Description
    Erector spinae plane block an effective block for postoperative analgesia in modified radical mastectomy.

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    ESP Block vs FIB in Patients Undergoing Hip Arthroplasty

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