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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
An intravenous bolus dose of dexamethasone given prior to surgery.
Hvidovre Hospital, Capital Region of Denmark.
Hvidovre, Denmark
Vejle Sygehus
Vejle, Denmark
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.
Time frame: 24 hours
Postoperative opioid usage
The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.
Time frame: 7 days
Postoperative antiemetics usage
The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
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