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This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fracture fixation | Fracture of upper or lower limbs or pelvis requiring internal fixation surgery |
| |
| Spinal fusion | Spinal fusion surgery |
| |
| Arthroplasty | Joint replacement surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal analgesia with oral strong opioids | Drug | Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores from baseline | Assess the efficacy of including oral strong opioids in multimodal pain control. For this objective, we will observe changes in pain scores among participants during postoperative treatment. | Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of adverse events | Avoid common adverse reactions associated with traditional morphine-like drugs, such as respiratory depression and addiction, to enhance treatment safety and patient comfort. We will monitor the occurrence rate of adverse reactions related to oral potent opioids. | During hospitalization (approximately within 1 week) |
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Inclusion Criteria:
(1) Fracture of upper or lower limbs or pelvis requiring internal fixation surgery (2) Spinal fusion surgery (3) Joint replacement surgery 3. Requiring multimodal analgesics for postoperative pain control, with oral strong opioids as the primary opioid analgesic, as assessed by his/her physician.
4. Voluntarily sign the informed consent form and agree to the collection of clinical questionnaires and medical-related information for this study.
Exclusion Criteria:
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Patients who are hospitalized for the following surgical treatment may be enrolled:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsu-te Yeh, MD | Contact | 886-2-87923311 | 88081 | tsutey@gmail.com |
| Tim TH Wang, PhD | Contact | 886-939081832 | asahi.tim@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tsu-te Yeh, MD | TriService General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriService General Hospital | Taipei | 114 | Taiwan |
Only anonymized and de-identified information can be collected from the participants as per institutional review board's approval.
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| Compliance of oral strong opioids | Improvement the convenience of analgesic medication by transitioning from injections to oral administration, making it easier for patients to accept and adhere to the treatment plan. The compliance rate of oral strong opioids will be measured. | During hospitalization (approximately within 1 week) |
| Physician's global impression - improvement scale(CGI-I) | Effectiveness of the pain control will be assessed by a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Scale 1= Very much improved and scale 7 = very much worse | During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery |
| Satisfation of the pain control as per patients' report outcome | Enhance patient acceptance of the treatment by using oral administration, boosting confidence in the treatment plan and increasing adherence and effectiveness. Patient satisfaction and pain improvement will be assessed through a 5-point scale questionnaire. 1=very much discontent, 2=discontent, 3=fair, 4=satisfied, 5=very much satisfied. | End of hospitalization (approximately 1 week after surgery) |