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Erector Spinae vs. Iliopsoas Plane Block for Total Hip Arthroplasty

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06083428
Collaborator
(none)
60
Enrollment
3
Arms
9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Effect of iliopsoas plane block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine 0.2% Injectable Solution
  • Drug: Ropivacaine 0.2% Injectable Solution
  • Drug: Control Test
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Iliopsoas Plane Block group

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

Drug: Ropivacaine 0.2% Injectable Solution
ultrasound guided iliopsoas plane block
Other Names:
  • iliopsoas plane block

    		•
    Active Comparator: ESPB group

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

    Drug: Ropivacaine 0.2% Injectable Solution
    ultrasound guided ESPB - L4 level, unilateral
    Other Names:
  • ESPB

    		•
    Active Comparator: Control group

    Only spinal anesthesia - No peripheral nerve block

    Drug: Control Test
    Only spinal anesthesia
    Other Names:
  • No peripheral nerve block

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption [48 hours after surgery]

      Total opiate consumption after surgery

    Secondary Outcome Measures

    1. first need of opiate [48 hours after procedure]

      Time after surgery when the patient needs opiate for the first time

    2. Numerical Rating Scale [range 0:10] [4 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    3. Numerical Rating Scale [range 0:10] [8 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    4. Numerical Rating Scale [range 0:10] [12 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    5. Numerical Rating Scale [range 0:10] [18 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    6. Numerical Rating Scale [range 0:10] [24 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    7. Numerical Rating Scale [range 0:10] [36 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    8. Numerical Rating Scale [range 0:10] [48 hours after surgery]

      Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    9. Neutrophil-to-lymphocyte ratio [24 hours after surgery]

      Neutrophil-to-lymphocyte ratio

    10. Neutrophil-to-lymphocyte ratio [48 hours after surgery]

      Neutrophil-to-lymphocyte ratio

    11. Platelet-to-lymphocyte ratio [24 hours after surgery]

      Platelet-to-lymphocyte ratio

    12. Platelet-to-lymphocyte ratio [48 hours after surgery]

      Platelet-to-lymphocyte ratio

    13. Quadriceps muscle strength assessed using medical research council scale [range 0:5] [Postoperative 24 hours period]

      Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Poznan University of Medical Sciences

    Investigators

    • Principal Investigator: Małgorzata Domagalska, Ph.D., Poznań University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poznan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT06083428
    Other Study ID Numbers:
    • 11/2023
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis, Hip
    Ropivacaine
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Oct 16, 2023