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| Name | Class |
|---|---|
| Sygehus Lillebaelt | OTHER |
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The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on postoperative pain and postoperative inflammation.
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting.
The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.
The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.
Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis on Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.
The two groups will be randomized and doubleblinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).
The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).
The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.
Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response. Also a series of blood tests determining the glucose-metabolism after the steroid-admission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Dexamethasone | Experimental | An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery. |
|
| Medium dose Dexamethasone | Active Comparator | An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | An intravenous bolus dose of dexamethasone given prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain after 24 hours: VAS | The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty. Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid usage | The amount of rescue opioids given in the postoperative period, and until 7 days after surgery. | 7 days |
| Postoperative antiemetics usage | The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward. | An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center. The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications. The outcome assesment will be descriptive. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolai Bang Foss, Dr.med. | Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital, Capital Region of Denmark. | Hvidovre | 2650 | Denmark | |||
| Vejle Sygehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36526481 | Derived | Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose dexamethasone in low pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2023 Mar;130(3):322-330. doi: 10.1016/j.bja.2022.10.038. Epub 2022 Dec 14. |
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Data will be available upon reasonable request
From 1 year after last included patient, and onto 4 years after end of trial.
Upon reasonable request to the corresponding author
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D020370 | Osteoarthritis, Knee |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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A randomized doubleblinded controlled trial.
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All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.
The Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.
| 7 days |
| The inflammatory response expressed by C-reactive protein(CRP). | The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone. | 2 days |
| Postoperative pain summed in the first 7 days | Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants. | 7 days |
| 7 days. |
| Vejle |
| 7100 |
| Denmark |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |