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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 total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption 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. Ropivacaine is a well-known local anesthetic. Adrenaline 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 Ropivacaine and Adrenaline combined with high dose systemic 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 two 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 placed 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 nerve block | Experimental | Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone |
|
| Local infiltrationanalgesia | Active Comparator | Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | 0 - 20 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | 0 - 24 hours postoperatively | |
| Pain Score by passive flexion of the knee joint from 0-90 degrees. | Using NRS (numeric rating scale) 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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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Runge, MD | Regionalhospital Silkeborg | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29346228 | Derived | Runge C, Jensen JM, Clemmesen L, Knudsen HB, Holm C, Borglum J, Bendtsen TF. Analgesia of Combined Femoral Triangle and Obturator Nerve Blockade Is Superior to Local Infiltration Analgesia After Total Knee Arthroplasty With High-Dose Intravenous Dexamethasone. Reg Anesth Pain Med. 2018 May;43(4):352-356. doi: 10.1097/AAP.0000000000000731. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2018 | |
| Reset | May 11, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2018 | May 11, 2018 |
| 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 |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| At timepoint 2 , 6, 20 and 24 hours postoperatively |
| Pain score at rest | Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The highest score since last score recorded. | At timepoint 2 , 6, 20 and 24 hours postoperatively |
| Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest) | Recorded at PCA(patient-controlled-analgesia) pump | 0-24 hours postoperatively |
| Nausea Score | NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea. The highest score since last score recorded. | At timepoint 2, 6, 20, 24 hours postoperatively |
| Number of vomiting | 0- 20 hours and 0-24 hours postoperatively |
| Consumption of Ondansetron | 0-20 hours and 0-24 hours |
| Reporting of dizziness Recording whether the dizziness is preventing mobilization. | Recording whether the dizziness is preventing | at timepoint 2, 6, 20 and 24 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. | 0-24 hours postoperatively |
| Discharge time from the hospital | maximum 60 hour postoperatively. |
| Preoperatively isometric tests of muscle strength in the hip adductors. | Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades. 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 nerve block is calculated. | pre and 30 minutes after block placement |
| Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses. | 0-24 hours posteratively |
| D000588 |
| Amines |
| 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 |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |