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.
Tri-Service General Hospital is the lead sponsor of 108 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who are hospitalized for the following surgical treatment may be enrolled:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Jul 2025, 11 months later.
How these figures are worked out, and which studies are left out of them.
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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