Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty (TKA)

Thammasat University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Dexamethasone; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02102815

OrthoTU06

Details and patient eligibility

About

To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.

Full description

Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.

Enrollment: 100 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
• 50-85 years old
• ASA class 1-3

Exclusion criteria

• Unable to perform spinal anaesthesia
• History of drug allergies: steroids
• Renal impairment (CrCl <30 mL/min)
• Liver impairment
• Cognitive function disorders
• Poor controlled DM (HA1C > 7.5)
• Morning DTX at operative day > 180 mg%
• Received corticosteroids within 3 months before surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Preoperative intravenous normal saline 50 mL slowly push over 5 minutes

Treatment:

Drug: Normal saline