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| ID | Type | Description | Link |
|---|---|---|---|
| 054/2559 | Other Grant/Funding Number | Faculty of medicine, Chiangmai university fund |
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To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs. |
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| Placebo | Placebo Comparator | The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Normal saline solution |
| Measure | Description | Time Frame |
|---|---|---|
| Modified WOMAC scores for pain at 12 weeks postoperative | using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scales for pain during a five-meter walk (0-100) | postoperatively at 24, 30, 48, 54, 72 hrs | |
| Visual analogue scales for pain during 45 degree active knee flexion (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitchanant Kitcharanant, MD | Contact | +66871071133 | nk_win@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nitchanant Kitcharanant, MD | Department of Orthopedics, Faculty of Medicine, Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Chiang Mai University | Recruiting | Chiang Mai | ChiangMai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58. | ||
| 39702151 | Derived | Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y. |
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| Visual analogue scales for current pain at rest in a supine position (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs |
| Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100) | postoperatively at 0-24, 24-48, 48-72 hrs |
| Visual analogue scale values for nausea (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs |
| Opioid consumption (mg.) | during the first 0-24, 24-48, and 48-72 hrs |
| Anti-emetic medicine consumption (mg.) | during the first 0-24, 24-48, and 48-72 hrs |
| Maximum degree of active knee flexion | postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks |
| Modified WOMAC scores for pain | using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire | postoperatively at weeks 2 and 6 |
| Wound complications | evaluated postoperatively at weeks 2, 6 and 12 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| 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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