Pain, Postoperative, Anesthesia, Local, Gonarthrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGUltrasound guided regional anesthesia
Applied perineurally preoperatively ultrasound guided regional anesthesia
Applied in the wound intraoperatively from the orthopedics
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult * non pregnant * patients with gonarthrosis who have given written consent for participation
Exclusion criteria
* Age below 18 years * pregnancy * breast-feeding patients * allergies against study medication * missing or denied written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need of opioid consumption in oral morphine equivalent | 48 hours postoperatively | consumed opioids in mg of oral morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain medication necessary | 5 days postoperatively or until discharge | Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day |
| Functionality of the prothesis - OKS (Oxford Knee Score) | 5 days postoperatively or until discharge | According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome) |
| Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score) | 5 days postoperatively or until discharge | According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome) |
| Pain assesment | 5 days postoperatively or until discharge | Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome) |
| Functionality of the prothesis- G-FJS (German Forgotten Joint Score) | 5 days postoperatively or until discharge | According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome) |
| Complications | 5 days postoperatively or until discharge | Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation) |
| procedure specific time | during surgery | time of the operation |
| Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | 5 days postoperatively or until discharge | According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome) |
Countries
Austria
Outcome results
None listed