High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Catastrophizing Pain
- Chronic Pain
- Hip Osteoarthritis
- Opioid Use
- Perioperative/Postoperative Complications
- Postoperative Nausea and Vomiting
- Postoperative Pain
- Surgery
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized double blinded controlled trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 90 years
- Gender
- Both males and females
Description
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders. The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intraven...
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders. 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 Hip Arthroplasty. Patients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at 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 double blinded. 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.
Tracking Information
- NCT #
- NCT03763760
- Collaborators
- Sygehus Lillebaelt
- Investigators
- Study Director: Nicolai Bang Foss, Dr.med. Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.
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