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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002769-72 | EudraCT Number |
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The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.
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Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial
Trial acronym: DEXRAR
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy.
Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia
Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v.
Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients.
Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Dexamethasone 24 mg i.v. after start of anaesthesia |
|
| Treatment B | Placebo Comparator | Saline isotonic i.v. after start of anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | A dose of 24 mg dexamethasone given after start of anaesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption the first 24 hours postoperatively | Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively | 0-24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during movement at 6 hours postoperatively (visual analogue scale) | Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100 | 6 hours postoperatively |
| Pain during movement at 24 hours postoperatively (visual analogue scale) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep (Verbal rating scale) | Level of quality of sleep. Verbal rating scale: very bad, fairly bad, fairly good, very good | 24 hours postoperatively |
| Blood sugar level at 6 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Hägi-Pedersen, MD | Department of Anaesthesiology, Næstved Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Næstved Hospital | Næstved | Region Sjælland | 4700 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline isotonic |
| Drug |
A dose of 6 ml of isotonic saline given after start of anaesthesia |
|
Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100 |
| 24 hours postoperatively |
| Pain at rest at 6 hours postoperatively (visual analogue scale) | Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100 | 6 hours postoperatively |
| Pain at rest at 24 hours postoperatively (visual analogue scale) | Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100 | 24 hours postoperatively |
| Timed up and go test | Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again | 24 hours postoperatively |
| Adverse events | Number of patients with one or more adverse events in the intervention period (0-24 hours) | 0 - 24 hours postoperatively |
| Nausea at 6 hours postoperatively (Verbal rating scale) | Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 6 hours postoperatively |
| Nausea at 24 hours postoperatively (Verbal rating scale) | Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 24 hours postoperatively |
| Vomiting the first 24 hours postoperatively | Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively | 0-24 hours postoperatively |
| Dizziness at 6 hours postoperatively (Verbal rating scale) | Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 6 hours postoperatively |
| Dizziness at 24 hours postoperatively (Verbal rating scale) | Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 24 hours postoperatively |
| Sedation at 6 hours postoperatively (Verbal rating scale) | Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 6 hours postoperatively |
| Sedation at 24 hours postoperatively (Verbal rating scale) | Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe | 24 hours postoperatively |
| Anti-emetic treatment the first 24 hours postoperatively | Consumption of ondansetron in the period 0-24 hours postoperatively | 0-24 hours postoperatively |
Level of blood sugar af 6 hours postoperatively in mmol/L
| 6 hours postoperatively |
| Blood sugar level at 24 hours postoperatively | Level of blood sugar at 24 hours postoperatively in mmol/L | 24 hours postoperatively |
| Number of patients with need for antibiotic treatment and/or reoperation within 90 days | Number of patients with need for antibiotic treatment and/or reoperation within 90 days after surgery | 0 - 90 days postoperatively |
| Serious adverse events | Serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to International Conference on Harmonization (ICH) - good clinical practice (GCP) - guidelines) except "prolongation of hospitalisation" | 0-90 days postoperatively |
| Days alive and outside hospital within 90 days after surgery | Days alive and outside hospital within 90 days after surgery | 0-90 days postoperatively |
| Quality of live, function | Oxford Knee Score (OKS) before surgery | Before surgery |
| Quality of live, function | Oxford Knee Score (OKS) 6 month after surgery | 6 month postoperatively |
| Quality of live, function | Oxford Knee Score (OKS) 12 month after surgery | 12 month postoperatively |
| Quality of live, function | EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) before surgery | Before surgery |
| Quality of live, function | EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 6 month after surgery | 6 month postoperatively |
| Quality of live, function | EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 12 month after surgery | 12 month postoperatively |
| Quality of live, function | Short Form 36 (SF-36) before surgery | Before surgery |
| Quality of live, function | Short Form 36 (SF-36) 6 month after surgery | 6 month postoperatively |
| Quality of live, function | Short Form 36 (SF-36) 12 month after surgery | 12 month postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |