Postoperative PainNCT04578483
Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
An observational study of Postoperative Pain, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Poor management of post-operative acute pain can contribute to medical complications including pneumonia, deep vein thrombosis, infection and delayed healing, as well as the development of chronic. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ERDS group
- Type of treatment
- Injection or infusion
- How many people
- 634 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Oct 2020to 31 Dec 2022
- How long will I take part?
- 16 Weeks
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having elective surgery in China Medical University Hsinchu Hospital were invited to participate in this study.
Who may be able to join
- Aged 20 to 80.
- Needing pain management after elective surgery.
- American Society of Anesthesiology Physical Class (ASA) between 1 and 3.
Who cannot join
- Allergic to anesthetics, opioids, or medicine used during study period.
- Severe comorbidity, such as cardiopulmonary disease and strock.
- Abuse or long-term use of opioids.
- Pregnant or breastfeeding.
- Judged to be unsuitable subjects by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Poor management of post-operative acute pain can contribute to medical complications including pneumonia, deep vein thrombosis, infection and delayed healing, as well as the development of chronic. In contrast, appropriate pain control is capable of reducing the postoperative complications, preventing the development of chronic pain, and improving the quality of life. The workloads of medical staffs and health care cost are subsequently decreased. Recently, a lot of analgesic methods have been developed and used in clinical practice, such as patient-controlled analgesia, ultrasound-guided long-term analgesia and multimodal analgesia. This study is aimed to investigate the effect of dinalbuphine sebacate, a long-acting analgesic, in postoperative pain management. This real world data can serve as a reference toward high health care quality.
Read the detailed description
This is a prospective, observational, cohort study. Patients undergoing elective surgery will be invited to the study. The written informed consent will be obtained prior to participation. Demographic data, underlying condition, surgical procedures, consumption of anesthetics and analgesics, analgesic methods, postoperative complications, pain intensity and life quality will be collected from medical history and by questionnaires.
- Conditions
- Postoperative Pain
- Being tested
- ERDS group
- Keywords
- Postoperative Pain, Analgesics, Analgesia, Dinalbuphine sebacate, Naldebain, PCA, Extended-release
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERDS groupOther
After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| ERDS group | Patients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be invited to participate in this study. Receives: Other: ERDS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (numerical rating scale)
Numerical rating scale (NRS) is used to assess pain intensity from surgical day (Day 0) to five days after surgery (Day 5). NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain).
Measured: From Day 0 to Day 5
Secondary outcomes (5)
Consumption of anesthetics
Amounts of medicines used during surgery are all analyzed, especially the ones related to analgesia.
Measured: From Day 0 to Day 5
Consumption of analgesics
Amounts of opioids are converted into morphine equivalents. Amounts of NSAIDs are calculated separately.
Measured: From Day 0 to Day 5
Adverse events
Percentage of the population suffering from postoperative adverse events are analyzed, especially the ones related to analgesics.
Measured: From Day 0 to Day 5
EQ-5D-5L score
EQ-5D-5L questionnaire is used to assess patients' life quality. Patients are asked to fill in the questionnaire prior to surgery, before discharge and/or three months after surgery.
Measured: Within 16 weeks after surgery
Patient satisfaction
Before discharge, patients are asked to rate satisfaction toward postoperative pain management on a 5-point scale: very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied.
Measured: Within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start27 Oct 2020
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 634 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kee-Ming Man, China Medical University Hospital
- Investigators
- Kee-Ming Man, MD, MS, Principal investigator, China Medical University Hsinchu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578483
- Sponsor's protocol ID
- CMUH109-REC3-101
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2020
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT04578483
- Acronym / sponsor ID
- CMUH109-REC3-101
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Analgesics, Analgesia, Dinalbuphine sebacate, Naldebain, PCA, Extended-release
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Oct 2020 (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.
Poor management of post-operative acute pain can contribute to medical complications including pneumonia, deep vein thrombosis, infection and delayed healing, as well as the development of chronic. In contrast, appropriate pain control is capable of reducing the postoperative complications, preventing the development of chronic pain, and improving the quality of life. The workloads of medical staffs and health care cost are subsequently decreased. Recently, a lot of analgesic methods have been developed and used in clinical practice, such as patient-controlled analgesia, ultrasound-guided long-term analgesia and multimodal analgesia. This study is aimed to investigate the effect of dinalbuphine sebacate, a long-acting analgesic, in postoperative pain management. This real world data can serve as a reference toward high health care quality.
Detailed description
This is a prospective, observational, cohort study. Patients undergoing elective surgery will be invited to the study. The written informed consent will be obtained prior to participation. Demographic data, underlying condition, surgical procedures, consumption of anesthetics and analgesics, analgesic methods, postoperative complications, pain intensity and life quality will be collected from medical history and by questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERDS group | – | Other: ERDS groupPatients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be invited to participate in this study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having elective surgery in China Medical University Hsinchu Hospital were invited to participate in this study.
Key inclusion criteria (3 listed)
- Aged 20 to 80.
- Needing pain management after elective surgery.
- American Society of Anesthesiology Physical Class (ASA) between 1 and 3.
Key exclusion criteria (5 listed)
- Allergic to anesthetics, opioids, or medicine used during study period.
- Severe comorbidity, such as cardiopulmonary disease and strock.
- Abuse or long-term use of opioids.
- Pregnant or breastfeeding.
- Judged to be unsuitable subjects by investigator.
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 |
|---|---|---|
| ERDS groupAfter anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance. | Other | ERDS group |
Primary outcome
Postoperative pain intensity (numerical rating scale)
Time frame: From Day 0 to Day 5
Numerical rating scale (NRS) is used to assess pain intensity from surgical day (Day 0) to five days after surgery (Day 5). NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain).
5 secondary outcomes
Consumption of anesthetics
Time frame: From Day 0 to Day 5
Consumption of analgesics
Time frame: From Day 0 to Day 5
Adverse events
Time frame: From Day 0 to Day 5
EQ-5D-5L score
Time frame: Within 16 weeks after surgery
Patient satisfaction
Time frame: Within 5 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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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.
Kee-Ming Man, MD, MS principal investigator
China Medical University Hsinchu 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 Postoperative Pain, run by China Medical University Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 25 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (numerical rating scale) (time frame: From Day 0 to Day 5). 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 25 Sep 2025.