An observational study in Orthopedic Procedures, Arthroplasty and Fracture Fixation, sponsored by Tri-Service General Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Tri-Service General Hospital · Observational
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.
Patients who are hospitalized for the following surgical treatment may be enrolled:
(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.
Exclusion Criteria:
Fracture of upper or lower limbs or pelvis requiring internal fixation surgery
Drug: Multimodal analgesia with oral strong opioids
Spinal fusion surgery
Drug: Multimodal analgesia with oral strong opioids
Joint replacement surgery
Drug: Multimodal analgesia with oral strong opioids
Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics
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.
Time frame: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
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.
Time frame: During hospitalization (approximately within 1 week)
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.
Time frame: 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
Time frame: 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.
Time frame: End of hospitalization (approximately 1 week after surgery)
Plan to share: No — Only anonymized and de-identified information can be collected from the participants as per institutional review board's approval.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital