Arthropathy of Knee, Knee Pain Chronic, Osteoarthritis, Knee
Conditions
Brief summary
"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards: The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation. The main questions the study aims to answer are: Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery. Participants will: Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation
Interventions
DRUGNaCl 0.9%
iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv
DRUGDexamethasone 4mg
iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients scheduled for total knee arthroplasty * patients aged \>65 and \<100 years * patients can provide informed consent * patients can reliably report symptoms to the research team
Exclusion criteria
* inability to provide first-party consent due to cognitive impairment or a * language barrier * infection at the site of the regional block, * coagulation disorders, * immunodeficiency, * American Society of Anesthesiologists (ASA) physical status of IV or higher, * history of regular steroid medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia | Time Frame: 48 hours after surgery | Time to first rescue analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | 48 hours after surgery | Total opioid consumption (mg) converted to morphine milligram equivalents (MME) |
| NRS | 4 hours after surgery | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") |
| NLR | 12 hours after surgery | Neutrophil-to-lymphocyte ratio |
| PLR | 12 hours after surgery | Platelet-to-lymphocyte ratio |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 4 hours after surgery | Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength |
| Nerve damage | 12 hours after surgery | Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome |
| glucose | 12 hours after surgery | blood glucose level |
Countries
Poland
Outcome results
None listed