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"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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | iPACK block with ACB |
|
| iv DEX | Active Comparator | iPACK block with ACB + iv Dexamethasone |
|
| pn DEX | Active Comparator | iPACK block with ACB + perineural Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl 0.9% | Drug | iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesia | Time to first rescue analgesia | Time Frame: 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | Total opioid consumption (mg) converted to morphine milligram equivalents (MME) | 48 hours after surgery |
| NRS | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | 62-701 | Poland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Dexamethasone 4mg | Drug | iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv |
|
|
| Dexamethasone 4mg | Drug | iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 2mg Dexamethasone) + 2ml 0.9% NaCl iv |
|
| 4 hours after surgery |
| NRS | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") | 8 hours after surgery |
| NRS | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") | 12 hours after surgery |
| NRS | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") | 24 hours after surgery |
| NRS | umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable") | 48 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 12 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 24 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 48 hours after surgery |
| PLR | Platelet-to-lymphocyte ratio | 12 hours after surgery |
| PLR | Platelet-to-lymphocyte ratio | 24 hours after surgery |
| PLR | Platelet-to-lymphocyte ratio | 48 hours after surgery |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 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 | 4 hours after surgery |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 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 | 8 hours after surgery |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 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 | 12 hours after surgery |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 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 | 24 hours after surgery |
| Quadriceps muscle strength assessed using medical research council scale [range 0:5] | 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 | 48 hours after surgery |
| Nerve damage | 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 | 12 hours after surgery |
| Nerve damage | 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 | 24 hours after surgery |
| Nerve damage | 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 | 48 hours after surgery |
| glucose | blood glucose level | 12 hours after surgery |
| glucose | blood glucose level | 24 hours after surgery |
| glucose | blood glucose level | 48 hours after surgery |
| D012216 |
| Rheumatic Diseases |
| D017670 |
| Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |