Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA

NCT06339151 | Active Not Recruiting DMC

• 1 other identifier: TUH multiple dexamethasone TKA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement. The main question\[s\] it aims to answer \[is/are\]: Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement? Researchers will compare double dose of dexamethasone group to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Conditions

Osteo Arthritis Knee; Pain, Postoperative

Keywords

total knee arthroplasty; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Pain at rest and motion

  Using visual analog scale 0-10 (0 means best, 10 means worst)

  At 6 hour, 12 hour, 18 hour, 24 hour, 30 hour, 36 hour, 42 hour, 48 hour, 54 hour, 60 hour, 66 hour and 72 hour after surgery

Secondary Outcomes (7)

• Nausea and vomiting

  At 24 hour, 48 hour and 72 hour after surgery

• Morphine consumption

  At 24 hour, 48 hour and 72 hour after surgery

• Blood sugar level

  At 24 hour and 48 hour after surgery

• CRP level

  At 24 hour and 48 hour after surgery

• Range of motion

  At 24 hour and 48 hour after surgery

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Normal saline solution injection

Drug: Dexamethasone before surgery

Group 2

ACTIVE COMPARATOR

Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Dexamethasone 0.15 mg/kg IV at 12 hours post operation Postoperative 24 hr - Normal saline solution injection

Drug: Dexamethasone before and 12 hours after surgery

Group 3

ACTIVE COMPARATOR

Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Dexamethasone 0.15 mg/kg IV at 24 hours post operation

Drug: Dexamethasone before and 24 hours after surgery

Interventions

Dexamethasone before surgery DRUG

Dexamethasone 0.15 mg/kg IV before surgery

Group 1

Dexamethasone before and 12 hours after surgery DRUG

Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 12 hours post operation

Group 2

Dexamethasone before and 24 hours after surgery DRUG

Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 24 hours post operation

Group 3

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary osteoarthritis of knee joint
• Undergo unilateral primary total knee replacement
• Age between 50-85 years old

You may not qualify if:

• Allergy to dexamethasone
• History of long term corticosteroid used
• New York heart association (NYHA) class \> II
• Type 2 Diabetes mellitus that had HbA1c \> 7 % or FBS \> 200 mg/dl
• Chronic kidney disease \> stage III or eGFR \< 60
• Cirrhosis Child class B or C
• Cannot use pain controlled as protocol
• History of previous knee surgery
• History of previous septic arthritis at knee joint

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (1)

• Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.

  PMID: 30033064 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: March 23, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)