The medical condition to be examined in this study is the first postoperative period after total knee replacement with a view to pain management. MedDRA version: 16.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Marcain-adrenalin
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: bupivacaine
Other descriptive name: BUPIVACAINE HYDROCHLORIDE
Concentration unit: mg mill
Sponsors
Thomas Fichtner Bendtsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age> 50 years • Patients set to cemented Total knee arthroplasty in spinal block • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully • ASA 1-3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Patients who can not cooperate with the investigation • Patients who do not understand or speak Danish • Patients receiving immunosuppressive therapy • Patients with a treatment-dependent diabetes mellitus • Patients with known neuropathy in the lower limbs • Allergy to those used in the study drugs • Alcohol and / or drug abuse - the investigator's opinion • Patients who can not tolerate NSAIDs • Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to investigate the effect of combined saphenous nerve and obturator nerve blockade with a mixture of local analgesics; bupivacain, adrenalin, clonidine and dexamethasone (protacted mixture), compared with saphenous nerve blockade with protracted mixture, compared with local infiltration analgesia in the tissue around the knee joint on opioid consumption after total knee arthroplasty.;Secondary Objective: Secondary it is to investigate the effect of combined saphenous nerve and obturator nerve blockade with protracted mixture, compared with saphenous nerve blockade with protracted mixture, compared with local infiltration analgesia in the tissue around the knee joint on pain, duration and mobilization after total knee arthroplasty.;Primary end point(s): • Consumption of opioid from 1 to 24 hours postoperatively, via patient-controlled analgesia-(PCA) pump. The patient is instructed to self-administer a dose when NRS (numeric rating scale) > 3 at rest.;Timepoint(s) of evaluation of this end point: Time 24 hours postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The total consumption of opioid from 1 to 48 hours postoperatively , at the PCA pump . • Pain Score with NRS - with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, by passive flexion of the knee joint from 0-90 degrees time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively . • Pain Score at rest recorded time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively . Where highest score since last score recorded. • Patient - record time of initial postoperative opioid pain breakthrough ( NRS > 3 at rest) • Nausea Score with NRS ( numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively . • Number of vomiting between 24 hours postoperatively . • Consumption of Ondansetron between 24 hours postoperatively . • Number of nights with patient-reported sleep disruptions during 48 hours postoperatively • Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu). The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general. • Discharge time from the hospital. • Patient - recorded consumption of opioids from the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively . • Quantitative satisfaction of pain 2 weeks postoperatively by indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction. • Mobilization and Function: • Isometric tests of muscle strength in the hip adductors by a handheld dynamometer before bringing nerve blokack (1-2 hours preoperatively) and again 30 minutes after the application of obturator nerve blockade. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest | — |
Countries
Denmark
Contacts
Public ContactCentre of elective surgery
Hospital of Silkeborg
Outcome results
None listed