Purpose: The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone ("protracted mixture") and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia. Background: Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity. Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment. Method The patient can receive one of three treatments, determined randomly: * A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline). * B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline). * C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic. Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received. The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram
Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram
Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg
Regional hospital Silkeborg
Silkeborg, Region Midt, Denmark
Opioid consumption
Time frame: 1 to 24 hours postoperatively
Opioid consumption
Time frame: 1 to 48 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees
numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable
Time frame: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively
Pain Score at rest
Numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable
Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively
Patient-reported time to first postoperative breakthrough pain
Time frame: Time 1 - 48 hours postoperatively
Nausea
numeric rating scale with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea
Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .
Vomiting
Time frame: Number of between 24 hours postoperatively
Ondansetron
Time frame: Consumption at time 24 hours postoperative
Number of nights with patient-reported sleep disruptions
Time frame: Time 48 hours postoperatively
Duration of stay in the post anesthesia care unit
Time frame: 1 - 48 hours postoperatively
Discharge time from the hospital
Time frame: Time 1 hour to 2 weeks postoperatively
Patient-reported consumption of opioid
Time frame: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively
Quantitative satisfaction of pain
By indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction.
Time frame: At 2 weeks postoperatively
Isometric tests of muscle strength in the hip adductors
The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after blockade construction calculated.
Time frame: 1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade
Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.
Time frame: Time 1 to 48 hours postoperatively
Timed Up and Go test
The patient rise from a chair and walk round 3 metres and sit on the chair again . The time for completion of the test are recorded .
Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
Cumulated Ambulation Score to illustrate the basic level of mobilization
The patient scores based on 3 gradations according to their ability to mobilize up and in bed, getting up from a chair and walk with or without aids in the form of high walker or crutches
Time frame: 1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively
Movement of the knee joint
The patient ability to extend and flex in the knee joint are recorded. The tests are performed with a goniometer
Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
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