Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine
- Conditions
- Pain, PostoperativeGonarthrosisAnesthesia, Local
- Interventions
- Drug: Ultrasound guided regional anesthesiaDrug: Local infiltration analgesia
- Registration Number
- NCT04697537
- Lead Sponsor
- Medical University of Graz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Adult
- non pregnant
- patients with gonarthrosis who have given written consent for participation
- Age below 18 years
- pregnancy
- breast-feeding patients
- allergies against study medication
- missing or denied written consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound guided regional anesthesia Ultrasound guided regional anesthesia 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 Local infiltration analgesia 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).
- Primary Outcome Measures
Name Time Method Need of opioid consumption in oral morphine equivalent 48 hours postoperatively consumed opioids in mg of oral morphine equivalent
- Secondary Outcome Measures
Name Time Method 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)
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)
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)
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
Trial Locations
- Locations (1)
Medical University Hospital LKH Graz
🇦🇹Graz, Austria