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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined saphenous nerve and obturator nerve block | Experimental |
| |
| Saphenous nerve block | Experimental |
| |
| Local infiltration analgesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram | Drug | Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | 1 to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional hospital Silkeborg | Silkeborg | Region Midt | 8600 | Denmark |
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| Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram | Drug | Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram |
|
| Ropivacaine + Toradol + Adrenaline | Drug | Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg |
|
| 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 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively |
| Patient-reported time to first postoperative breakthrough pain | 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 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively . |
| Vomiting | Number of between 24 hours postoperatively |
| Ondansetron | Consumption at time 24 hours postoperative |
| Number of nights with patient-reported sleep disruptions | Time 48 hours postoperatively |
| Duration of stay in the post anesthesia care unit | 1 - 48 hours postoperatively |
| Discharge time from the hospital | Time 1 hour to 2 weeks postoperatively |
| Patient-reported consumption of opioid | 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. | 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. | 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 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 . | 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 | 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 | 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| D020911 | Ketorolac Tromethamine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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