Orthopedic ProceduresORORANCT06554457
Post Surgical Multimodal Analgesia With Oral Strong Opioids
An observational study of Orthopedic Procedures and Arthroplasty, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Procedures, Arthroplasty, Fracture Fixation
- What is being tested?
- Multimodal analgesia with oral strong opioids
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Aged 18 or older
- Must undergo one of the following treatments:
- 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.
Who cannot join
- Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).
- Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
- Patients who use patient-controlled analgesics for pain control after surgery.
- Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
- Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.
- Other cases deemed ineligible by the study investigator.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
TriService General Hospital
Taipei, 114
Tsu-te Yeh, MD, tsutey@gmail.com
About this study
Official title: Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia
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.
- Conditions
- Orthopedic Procedures, Arthroplasty, Fracture Fixation
- Being tested
- Multimodal analgesia with oral strong opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal analgesia with oral strong opioidsDrug
Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics
| Study group | Role | What they receive |
|---|---|---|
| Fracture fixation | Fracture of upper or lower limbs or pelvis requiring internal fixation surgery Receives: Drug: Multimodal analgesia with oral strong opioids | |
| Spinal fusion | Spinal fusion surgery Receives: Drug: Multimodal analgesia with oral strong opioids | |
| Arthroplasty | Joint replacement surgery Receives: Drug: Multimodal analgesia with oral strong opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
Secondary outcomes (4)
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.
Measured: 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.
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
Measured: 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.
Measured: End of hospitalization (approximately 1 week after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start12 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsu-Te Yeh, Tri-Service General Hospital (TSGH)
- Investigators
- Tsu-te Yeh, MD, Principal investigator, TriService General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554457
- Sponsor's protocol ID
- ORORA24
- Acronym
- ORORA
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only anonymized and de-identified information can be collected from the participants as per institutional review board's approval.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia
- ClinicalTrials.gov ID
- NCT06554457
- Acronym / sponsor ID
- ORORA / ORORA24
- Conditions
- Orthopedic Procedures, Arthroplasty, Fracture Fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 12 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fracture fixation | – | Drug: Multimodal analgesia with oral strong opioidsFracture of upper or lower limbs or pelvis requiring internal fixation surgery |
| Spinal fusion | – | Drug: Multimodal analgesia with oral strong opioidsSpinal fusion surgery |
| Arthroplasty | – | Drug: Multimodal analgesia with oral strong opioidsJoint replacement surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Aged 18 or older
- Must undergo one of the following treatments:
- 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.
Key exclusion criteria (6 listed)
- Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).
- Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
- Patients who use patient-controlled analgesics for pain control after surgery.
- Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
- Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal analgesia with oral strong opioidsPhysician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics | Drug | Arthroplasty, Fracture fixation, Spinal fusion |
Primary outcome
Change in pain scores from baseline
Time frame: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
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.
4 secondary outcomes
Occurence of adverse events
Time frame: During hospitalization (approximately within 1 week)
Compliance of oral strong opioids
Time frame: During hospitalization (approximately within 1 week)
Physician's global impression - improvement scale(CGI-I)
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
Time frame: End of hospitalization (approximately 1 week after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No. Only anonymized and de-identified information can be collected from the participants as per institutional review board's approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsu-te Yeh, MD principal investigator
TriService General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Procedures and Arthroplasty, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsu-te Yeh, MD (886-2-87923311 ext. 88081, tsutey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores from baseline (time frame: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.