The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

Phase 4

Terminated

• Conditions: Pain, Postoperative; Arthroplasty, Knee Replacement
• Interventions: Drug: Sodium Chloride, (24)NaCl 0,9%; Drug: Dexamethasone

• Registration Number: NCT03034733
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Study Start: 2017-02-15
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride, (24)NaCl 0,9%	Sodium Chloride, (24)NaCl 0,9%	single-dose intravenous saline, intraoperative
dexamethasone 0,15 mg/kg	Dexamethasone	single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative
dexamethasone 0,25 mg/kg	Dexamethasone	single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative

Primary Outcome Measures

Name	Time	Method
pain during walking, NRS 0-10	at 24 hours postoperatively	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

Secondary Outcome Measures

Name	Time	Method
general wellbeing, NRS 0-10	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours	NRS (numerical rating scale: 0=worst, 10 = best)
nausea, NRS 0-10	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours	NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)
pain during walking, NRS 0-10	preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
vomiting, yes/no	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours	vomiting, yes/no
consumption of intravenous oxycodone, milligrams/kilogram body weight	postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours	cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device
quality of sleep, NRS 0-10	postoperatively at 24 hours, at 48 hours	NRS (numerical rating scale: 0=worst, 10 = best)
time to achieve discharge criteria, hours	postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours	time to achieve discharge criteria, hours
pain at rest, NRS 0-10	preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, OYS, Finland