Chronic Pain Clinical Trial
Official title:
High-Dose Steroids in High Pain Responders Undergoing Total Knee-arthroplasty: A Randomized Double Blinded Controlled Trial
Verified date | June 2021 |
Source | Copenhagen University Hospital, Hvidovre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.
Status | Completed |
Enrollment | 88 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age between 40 and 90. - Booked for unilateral knee-arthroplasty. - Is able to take part in the investigation(selfreported pain and nausea/vomiting) - Understands Danish or English, or has a translator available. - Signed written consent. - A daily use of 30 mg or more of morphine or morphine equivalents . - A pain catastrophizing scale(PCS) score of >20. Exclusion Criteria: - Insulin-dependent diabetes melitus. - Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids). - Pregnancy/Breastfeeding - Allergies for the investigational drug. - A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital, Capital Region of Denmark. | Hvidovre | |
Denmark | Vejle Sygehus | Vejle |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital, Hvidovre | Sygehus Lillebaelt |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. |
7 days. | |
Primary | 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 | |
Secondary | Postoperative opioid usage | The amount of rescue opioids given in the postoperative period, and until 7 days after surgery. | 7 days | |
Secondary | Postoperative antiemetics usage | The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery. | 7 days | |
Secondary | 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 | |
Secondary | Postoperative pain summarized 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.
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS >30 mm. |
7 days |
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