Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

Postoperative Pain Clinical Trial

— TKA  

Official title:

Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102815
• Other study ID #: OrthoTU06
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes
• Normal saline
NSS 50 mL IV slowly push over 5 minutes

Locations

Country	Name	City	State
Thailand	Orthopaedic department, Faculty of medicine, Thammasat university	Klongluang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee range of motion	measuring range of motion with goniometer	3 months
Primary	post-operative pain	measured with VAS for pain, drugs for relief pain	48 hours
Secondary	Functional knee score	measured with WOMAC, KSS	3 month
Secondary	post-operative nausea and vomiting	measured with amount of nausea/vomiting and drugs requiring for fixed its.	48 hours
Secondary	complication of preoperative dexamethasone	measured with wound complication, blood sugar level	2 weeks
Secondary	inflammatory level	CRP level	48 hours