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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06083428
Other study ID # 11/2023
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 17, 2023
Est. completion date May 30, 2024

Study information

Verified date April 2024
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 90
Est. completion date May 30, 2024
Est. primary completion date April 26, 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

Study Design


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
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