Erector Spinae vs. PENG Block for Total Hip Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Hip Osteoarthritis; Hip Arthropathy
• Intervention / Treatment: Drug: Control Test; Drug: Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block; Drug: Ropivacaine 0.2% Injectable Solution - PENG block

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESPB group; ultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine	Drug: Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block; ultrasound guided ESPB - L4 level, unilateral; Other Names: Erector Spinae Plane Block
Active Comparator: Control group; Only spinal anesthesia - No peripheral nerve block	Drug: Control Test; Only spinal anesthesia; Other Names: No peripheral nerve block
Active Comparator: PENG Block group; ultrasound guided PENG block - 20ml 0,2% ropivacaine	Drug: Ropivacaine 0.2% Injectable Solution - PENG block; ultrasound guided PENG block; Other Names: PENG block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Total opiate consumption after surgery	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
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)	4 hours after surgery
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)	8 hours after surgery
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)	12 hours after surgery
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)	18 hours after surgery
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)	24 hours after surgery
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)	36 hours after surgery
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)	48 hours after surgery
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	24 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	48 hours after surgery
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	Postoperative 24 hours period

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Małgorzata Domagalska, Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 11/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No