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Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided regional anesthesia | Active Comparator | Patient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml). |
|
| Local infiltration analgesia | Active Comparator | Patient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided regional anesthesia | Drug | Applied perineurally preoperatively ultrasound guided regional anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need of opioid consumption in oral morphine equivalent | consumed opioids in mg of oral morphine equivalent | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assesment | Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome) | 5 days postoperatively or until discharge |
| Pain medication necessary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregor A Schittek, MD | Med Uni Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Hospital LKH Graz | Graz | 8036 | Austria |
Data will be made available upon reasonable request
Data will be made available upon reasonable request
Data will be made available upon reasonable request
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| Local infiltration analgesia | Drug | Applied in the wound intraoperatively from the orthopedics |
|
|
Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day
| 5 days postoperatively or until discharge |
| Functionality of the prothesis - OKS (Oxford Knee Score) | According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome) | 5 days postoperatively or until discharge |
| Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score) | According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome) | 5 days postoperatively or until discharge |
| Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome) | 5 days postoperatively or until discharge |
| Functionality of the prothesis- G-FJS (German Forgotten Joint Score) | According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome) | 5 days postoperatively or until discharge |
| Complications | Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation) | 5 days postoperatively or until discharge |
| procedure specific time | time of the operation | during surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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