- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06339151
Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA
Efficacy of Intravenous Dexamethasone Injection Given 12 and 24 Hours for Pain After Total Knee Arthroplasty: A Prospective Randomized Clinical Trial
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].
Study Overview
Status
Conditions
Detailed Description
Randomized patients into 3 groups
- Group 1: Patients received only Dexamethasone 0.15 mg/kg IV before surgery.
- Group 2: Patients received Dexamethasone 0.15 mg/kg IV before surgery and Dexamethasone 0.15 mg/kg at 12 hours after surgery.
- Group 3: Patients received Dexamethasone 0.15 mg/kg before surgery along and Dexamethasone 0.15 mg/kg at 24 hours after surgery.
- Preemptive analgesia Alprazolam 0.5 mg. 1 tablet, Pregabalin 75 mg. 1 tablet before bedtime Celecoxib 400 mg. 1 tablet, Omeprazole 20 mg 1 mg tablet, Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery.
- The researcher will give an injection. Dexamethasone 0.15 mg/kg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery.
- Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 0.5% Bupivacaine 15 mg, which does not contain morphine, along with local anesthesia in the thigh area (Adductor canal block) with a mixture of 0.5% Bupivacaine 15 mg.
- All patients will undergo knee replacement surgery in the same manner
- Periarticular cocktail injection The drug contains Tranexamic acid 10 mg/kg, Morphine 5 mg, Adrenaline 0.5 mg, 5% Bupivacaine 200 mg (Marcaine 1 amp), Ketorolac 30 mg (1 amp) mixed with saline (Normal saline) until 75 ml of area is obtained. The injection site is placed around the knee joint and knee capsule.
- After surgery, the patient will stay in the recovery room for 2 hours to take care of their symptoms.
Pain relievers after surgery include
- Parecoxib (Dynastat) 40 mg injection every 12 hours for the first 2 days after knee replacement surgery, then change the medicine to Celecoxib 400 mg. 1 tablet after breakfast
- Paracetamol 500 mg. 2 tablets every 6 hours for the first 2 days after knee replacement surgery. After that, give Paracetamol 500 mg. 2 tablets pro for pain every 6 hours
- Pregabalin 75 mg. 1 tablet po hs
- Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points (VAS-P score ≥4)
- Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours
- Alprazolam 0.5 mg 1 tab po hs
- Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery
- Group 2 patients will receive Dexamethasone 0.15 mg/kg as an injection after surgery at 12 hours, and patients in Group 3 will receive Dexamethasone 0.15 mg/kg as injection at 24 hours after surgery
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yot Tanariyakul, M.D.
- Phone Number: 6683930257
- Email: y.tanariyakul@gmail.com
Study Locations
-
-
Pathum Thani
-
Khlong Luang, Pathum Thani, Thailand, 12120
- Recruiting
- Thammasat University Hospital
-
Principal Investigator:
- Piya Pinsornsak, M.D.
-
Contact:
- Yot Tanariyakul, M.D.
- Phone Number: 6683930257
- Email: y.tanariyakul@gmail.com
-
Principal Investigator:
- Yot Tanariyakul, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of primary osteoarthritis of knee joint
- Undergo unilateral primary total knee replacement
- Age between 50-85 years old
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
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 |
Dexamethasone 0.15 mg/kg IV before surgery
|
Active Comparator: Group 2
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 |
Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 12 hours post operation
|
Active Comparator: Group 3
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 |
Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 24 hours post operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at rest and motion
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea and vomiting
Time Frame: At 24 hour, 48 hour and 72 hour after surgery
|
Using visual analog scale 0-10 (0 means best, 10 means worst)
|
At 24 hour, 48 hour and 72 hour after surgery
|
Morphine consumption
Time Frame: At 24 hour, 48 hour and 72 hour after surgery
|
Total milligrams use of morphine postoperative (record in mg)
|
At 24 hour, 48 hour and 72 hour after surgery
|
Blood sugar level
Time Frame: At 24 hour and 48 hour after surgery
|
record in mg/dL
|
At 24 hour and 48 hour after surgery
|
CRP level
Time Frame: At 24 hour and 48 hour after surgery
|
record in mg/dL
|
At 24 hour and 48 hour after surgery
|
Range of motion
Time Frame: At 24 hour and 48 hour after surgery
|
Using long arm goniometer (record in degrees)
|
At 24 hour and 48 hour after surgery
|
Length of hospital stay
Time Frame: up to 1 week
|
Number of days the patient stays for surgery
|
up to 1 week
|
Complication
Time Frame: up to 6 months
|
Surgical site infection, deep infection or wound complication
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Pain, Postoperative
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- TUH multiple dexamethasone TKA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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