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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].
Randomized patients into 3 groups
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone before surgery | Drug | Dexamethasone 0.15 mg/kg IV before surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and vomiting | Using visual analog scale 0-10 (0 means best, 10 means worst) | At 24 hour, 48 hour and 72 hour after surgery |
| Morphine consumption | Total milligrams use of morphine postoperative (record in mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30033064 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
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| 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 |
|
| 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 |
|
| At 24 hour, 48 hour and 72 hour after surgery |
| Blood sugar level | record in mg/dL | At 24 hour and 48 hour after surgery |
| CRP level | record in mg/dL | At 24 hour and 48 hour after surgery |
| Range of motion | Using long arm goniometer (record in degrees) | At 24 hour and 48 hour after surgery |
| Length of hospital stay | Number of days the patient stays for surgery | up to 1 week |
| Complication | Surgical site infection, deep infection or wound complication | up to 6 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005159 |
| Health Care Facilities Workforce and Services |