search
Back to results

Erector Spinae vs. Iliopsoas Plane Block for Total Hip Arthroplasty

Primary Purpose

Hip Arthropathy, Hip Osteoarthritis, Hip Pain Chronic

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
Ropivacaine 0.2% Injectable Solution
Control Test
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia. Exclusion Criteria: Patients who have a history of bleeding diathesis, Take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Iliopsoas Plane Block group

    ESPB group

    Control group

    Arm Description

    ultrasound guided iliopsoas plane block - 20ml 0,2% ropivacaine

    ultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine

    Only spinal anesthesia - No peripheral nerve block

    Outcomes

    Primary Outcome Measures

    Opioid consumption
    Total opiate consumption after surgery

    Secondary Outcome Measures

    first need of opiate
    Time after surgery when the patient needs opiate for the first time
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Numerical Rating Scale [range 0:10]
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Neutrophil-to-lymphocyte ratio
    Neutrophil-to-lymphocyte ratio
    Neutrophil-to-lymphocyte ratio
    Neutrophil-to-lymphocyte ratio
    Platelet-to-lymphocyte ratio
    Platelet-to-lymphocyte ratio
    Platelet-to-lymphocyte ratio
    Platelet-to-lymphocyte ratio
    Quadriceps muscle strength assessed using medical research council scale [range 0:5]
    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Poznan University of Medical Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06083428
    Brief Title
    Erector Spinae vs. Iliopsoas Plane Block for Total Hip Arthroplasty
    Official Title
    Erector Spinae Plane Block (ESPB) vs. Iliopsoas Plane Block for Pain Management and Stress Response in Patients Undergoing Total Hip Arthroplasty. A Prospective, Randomized Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    Effect of iliopsoas plane block and ESPB on pain management, and NLR and PLR following knee arthroplasty
    Detailed Description
    Hip arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects. In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR. This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing hip replacement surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthropathy, Hip Osteoarthritis, Hip Pain Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Iliopsoas Plane Block group
    Arm Type
    Active Comparator
    Arm Description
    ultrasound guided iliopsoas plane block - 20ml 0,2% ropivacaine
    Arm Title
    ESPB group
    Arm Type
    Active Comparator
    Arm Description
    ultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Only spinal anesthesia - No peripheral nerve block
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine 0.2% Injectable Solution
    Other Intervention Name(s)
    ESPB
    Intervention Description
    ultrasound guided ESPB - L4 level, unilateral
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine 0.2% Injectable Solution
    Other Intervention Name(s)
    iliopsoas plane block
    Intervention Description
    ultrasound guided iliopsoas plane block
    Intervention Type
    Drug
    Intervention Name(s)
    Control Test
    Other Intervention Name(s)
    No peripheral nerve block
    Intervention Description
    Only spinal anesthesia
    Primary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    Total opiate consumption after surgery
    Time Frame
    48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    first need of opiate
    Description
    Time after surgery when the patient needs opiate for the first time
    Time Frame
    48 hours after procedure
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    4 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    8 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    12 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    18 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    24 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    36 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
    Time Frame
    48 hours after surgery
    Title
    Neutrophil-to-lymphocyte ratio
    Description
    Neutrophil-to-lymphocyte ratio
    Time Frame
    24 hours after surgery
    Title
    Neutrophil-to-lymphocyte ratio
    Description
    Neutrophil-to-lymphocyte ratio
    Time Frame
    48 hours after surgery
    Title
    Platelet-to-lymphocyte ratio
    Description
    Platelet-to-lymphocyte ratio
    Time Frame
    24 hours after surgery
    Title
    Platelet-to-lymphocyte ratio
    Description
    Platelet-to-lymphocyte ratio
    Time Frame
    48 hours after surgery
    Title
    Quadriceps muscle strength assessed using medical research council scale [range 0:5]
    Description
    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
    Time Frame
    Postoperative 24 hours period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia. Exclusion Criteria: Patients who have a history of bleeding diathesis, Take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Malgorzata Domagalska, Ph.D.
    Phone
    608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Małgorzata Domagalska, Ph.D.
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Erector Spinae vs. Iliopsoas Plane Block for Total Hip Arthroplasty

    We'll reach out to this number within 24 hrs