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Completed

NCT Number: NCT06083428

Erector Spinae vs. PENG Block for Total Hip Arthroplasty

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

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Key information

Conditions

Hip Arthropathy Arthritis Hip Osteoarthritis Hip Pain Chronic Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block

Drug

ultrasound guided ESPB - L4 level, unilateral

Other names: Erector Spinae Plane Block

Ropivacaine 0.2% Injectable Solution - PENG block

Drug

ultrasound guided PENG block

Other names: PENG block

Control Test

Drug

Only spinal anesthesia

Other names: No peripheral nerve block

Primary outcomes

  1. Opioid consumption

    Time frame: 48 hours after surgery

    Total opiate consumption after surgery

Secondary outcomes

  1. first need of opiate

    Time frame: 48 hours after procedure

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

  2. Numerical Rating Scale [range 0:10]

    Time frame: 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]

    Time frame: 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]

    Time frame: 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]

    Time frame: 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]

    Time frame: 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]

    Time frame: 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]

    Time frame: 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

    Time frame: 24 hours after surgery

    Neutrophil-to-lymphocyte ratio

  10. Neutrophil-to-lymphocyte ratio

    Time frame: 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  11. Platelet-to-lymphocyte ratio

    Time frame: 24 hours after surgery

    Platelet-to-lymphocyte ratio

  12. Platelet-to-lymphocyte ratio

    Time frame: 48 hours after surgery

    Platelet-to-lymphocyte ratio

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

    Time frame: Postoperative 24 hours period

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

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Erector Spinae Plane Block (ESPB) vs. PENG Block for Pain Management and Stress Response in Patients Undergoing Total Hip Arthroplasty. A Prospective, Randomized Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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