The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

University of Oulu

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative; Arthroplasty, Knee Replacement

Treatments: Drug: Sodium Chloride, (24)NaCl 0,9%; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03034733

Polvitepdexa 24052016

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 3 patient groups, including a placebo group

dexamethasone 0,15 mg/kg

Experimental group

Description:

single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative

Treatment:

Drug: Dexamethasone

dexamethasone 0,25 mg/kg

Experimental group

Description:

single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative

Treatment:

Drug: Dexamethasone

Sodium Chloride, (24)NaCl 0,9%

Placebo Comparator group

Description:

single-dose intravenous saline, intraoperative

Treatment:

Drug: Sodium Chloride, (24)NaCl 0,9%