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To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg intravenous Dexamethasone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline Solution | Placebo Comparator | The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia . |
|
| 10 mg Dexamethasone | Active Comparator | The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia |
|
| 40 mg Dexamethasone | Active Comparator | The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Normal Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scales for pain during five-metre walking (0-100) | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; | at 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scales for pain during five-metre walking (0-100) | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; | Postoperative at 48,72 hours. |
| Visual analogue scales for pain on 45 degree active hip flexion (0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vutinan Manassoontornvuti, MD | Contact | +66909712741 | m.vutinan@gmail.com | |
| Nitchanant Kitcharanant, MD | Contact | +66871071133 | nk_win@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Chiang Mai University | Recruiting | Chiang Mai | 50200 | Thailand |
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| Drug |
|
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
| Postoperative at 24,48,72 hours. |
| Visual analogue scales for current pain at rest on supine position (0-100) | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; | Postoperative at 6,24,48,72 hours. |
| Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100) | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; | Postoperative at 0-24,24-48,48-72 hours. |
| Visual analogue scales for nausea (0-100) | This outcome will be assessed in a form of visual analogue scale of 0-100 mm, in which 0 indicates no nausea or vomiting and 100 indicates the worst nausea or vomiting | Postoperative at 6,24,48,72 hours |
| Opioid consumption (mg.) | Opioid consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours |
| Anti-emetic medicine consumption (mg.) | Anti-emetic medicine consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours |
| Wound complication | Wound complications (including periprosthetic joint infection and inadequate wound healing). Periprosthetic joint infection will be diagnosed using the criteria outlined by the Musculoskeletal Infection Society. Inadequate wound healing is defined as delayed wound healing or wound dehiscence | Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks. |
| ID | Term |
|---|---|
| D004194 | Disease |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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