Regional hospital Silkeborg
Silkeborg, Region Midt, 8600, Denmark
NCT Number: NCT02067078
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 4
Silkeborg, Region Midt, 8600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 to 24 hours postoperatively
Time frame: 1 to 48 hours postoperatively
Time frame: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively
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
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 - 48 hours postoperatively
Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .
numeric rating scale with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea
Time frame: Number of between 24 hours postoperatively
Time frame: Consumption at time 24 hours postoperative
Time frame: Time 48 hours postoperatively
Time frame: 1 - 48 hours postoperatively
Time frame: Time 1 hour to 2 weeks postoperatively
Time frame: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively
Time frame: At 2 weeks postoperatively
By indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction.
Time frame: 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 value for the test before and after blockade construction calculated.
Time frame: Time 1 to 48 hours postoperatively
Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
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 pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively
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 preoperatively, 24 hours and 2 weeks postoperatively
The patient ability to extend and flex in the knee joint are recorded. The tests are performed with a goniometer
Regionshospitalet Silkeborg
Other
The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty.
Acronym: Hobsali
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