The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

Phase 4TerminatedNCT03034733

University of Oulu27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Arthroplasty, Knee Replacement Pain, Postoperative

Interventions

DexamethasoneDRUG

intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg

Sodium Chloride, (24)NaCl 0,9%DRUG

intravenous placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Oulu University Hospital

Oulu, OYS, Finland

Outcomes

Primary Outcomes

pain during walking, NRS 0-10

NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

Time frame: at 24 hours postoperatively

Secondary Outcomes

pain at rest, NRS 0-10

NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

Time frame: preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day

consumption of intravenous oxycodone, milligrams/kilogram body weight

cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device

Time frame: postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours

nausea, NRS 0-10

NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)

Time frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

general wellbeing, NRS 0-10

NRS (numerical rating scale: 0=worst, 10 = best)

Time frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

quality of sleep, NRS 0-10

NRS (numerical rating scale: 0=worst, 10 = best)

Time frame: postoperatively at 24 hours, at 48 hours

time to achieve discharge criteria, hours

Time frame: postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours

Data from ClinicalTrials.gov

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