Clinical trial NCT03034733: The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery
Official title: The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthroplasty, Knee Replacement
Pain, Postoperative
Keywords: Arthroplasty
Knee Replacement
Pain, Postoperative
Glucocorticoids
Dexamethasone
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.

Detailed description: The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone.

Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied.

Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.

Eligibility criteria: Inclusion Criteria:

* primary total knee replacement surgery
* ASA (american society of anesthesiologists) class 1-3

Exclusion Criteria:

* severe coronary artery disease, heart failure, kidney failure
* insulin-dependent DM (diabetes mellitus), poorly controlled type II DM
* gastric/duodenal ulcer
* allergy/contra-indication for any drug used in the study
* corticosteroid use during last 3 months
* preoperative use of opioid drugs (excl. codeine, tramadol)
* neuropathy/sensory impairment of lower limbs
* lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device

Primary outcomes:
measure: pain during walking, NRS 0-10
timeFrame: at 24 hours postoperatively
Secondary outcomes:
measure: pain at rest, NRS 0-10
timeFrame: preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day
measure: consumption of intravenous oxycodone, milligrams/kilogram body weight
timeFrame: postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours
measure: nausea, NRS 0-10
timeFrame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
measure: general wellbeing, NRS 0-10
timeFrame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
measure: quality of sleep, NRS 0-10
timeFrame: postoperatively at 24 hours, at 48 hours
measure: time to achieve discharge criteria, hours
timeFrame: postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours
measure: pain during walking, NRS 0-10
timeFrame: preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day
measure: vomiting, yes/no
timeFrame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Other outcomes:
measure: blood glucose, mmol/l
timeFrame: at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours
measure: inflammatory reaction, c-reactive protein (CRP)
timeFrame: preoperative, postoperatively: at 24 hours, 48 hours
measure: wound complication, yes/no
timeFrame: postoperatively up to 90 days
measure: wound infection, yes/no
timeFrame: postoperatively up to 90 days
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
state: OYS
Study officials:
affiliation: Oulu University Hospital
name: Matti Kyllönen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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