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To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty
A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dinalbuphine Sebacate | Experimental | Naldebain 150mg/2mL IM |
|
| Placebo | Placebo Comparator | Normal saline 2 mL IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinalbuphine Sebacate | Drug | Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for pain (VAS 0-100) | Visual analog scale for pain at rest and on motion (knee flexion 90 degrees) using 0-100 mm, where a score of 0 represented no pain and 100 indicated the most severe pain | Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of analgesic drug used | The amount of IV morphine and oral tramadol (milligram) | During hospitalization and at home until 12 weeks after surgery |
| Adverse effects | Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of closed manipulation | Closed manipulation under anesthesia due to an unsatisfactory range of motion | At 3 months postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Supakit Kanitnate, M.D. | Contact | +66 899853635 | naypeng@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27518486 | Result | Yeh CY, Jao SW, Chen JS, Fan CW, Chen HH, Hsieh PS, Wu CC, Lee CC, Kuo YH, Hsieh MC, Huang WS, Chung YC, Liou TY, Chiu HH, Tseng WK, Lee KC, Wang JY. Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia: A Multicenter, Randomized, Double-Blind, And Placebo-controlled Study in Hemorrhoidectomy Patients. Clin J Pain. 2017 May;33(5):429-434. doi: 10.1097/AJP.0000000000000417. |
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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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block |
|
| The first week after surgery |
| Length of stay | Length of stay (day) | During hospitalization (from admission to discharge) |
| Modified WOMAC score | Modified Western Ontario and McMaster Universities Osteoarthritis Index score, including total & subscore. Each item was scored with a Likert scale (0-4). The overall MOWAC was 0-96 (high score = worse symptoms) | At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively |
| Forgotten Joint Score | Forgotten Joint Score (Thai version) with 12 questions. Each item was scored on a Likert scale (0-4). The raw score was converted to a 0-100 scale (0 = worst, 100 = best) | At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively |
| Time up and go (TUG) test | Time up and go (TUG) test records the time in seconds when the patient starts standing up from the chair, then walks 3 meters at a normal pace, and turns around to sit on the chair. | At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively |
| Knee range of motion | Angle of knee flexion and extension in degrees using a long goniometer | At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |