Erector Spinae vs. PENG Block for Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06083428
• Other study ID #: 11/2023
• Status: Completed
• Phase: Phase 4
• Start date: October 17, 2023
• Est. completion date: June 11, 2024

Study information

• Verified date: June 2024
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 11, 2024
• Est. primary completion date: June 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Hip Osteoarthritis
• Hip Pain Chronic
• Osteoarthritis, Hip

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block
ultrasound guided ESPB - L4 level, unilateral
• Ropivacaine 0.2% Injectable Solution - PENG block
ultrasound guided PENG block
• Control Test
Only spinal anesthesia

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Total opiate consumption after surgery	48 hours after surgery
Secondary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Secondary	Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Secondary	Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	24 hours after surgery
Secondary	Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	48 hours after surgery
Secondary	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