Pain, PostoperativePhase 4NCT05825495
Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
A Phase 4 study testing Dinalbuphine sebacate and Routine practice in people with Pain, Postoperative and Obstructive Sleep Apnea-hypopnea Syndrome, run by Li-Jen Hsin.
Trial summary
This is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pain, Postoperative, Obstructive Sleep Apnea-hypopnea Syndrome, Pain, Acute
- What is being tested?
- Dinalbuphine sebacate and Routine practice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 65.
- diagnosed with obstructive sleep apnea.
- arranged to undergo uvulopalatopharyngoplasty.
- classified as ASA I, II, or III.
Who cannot join
- can not comply with study protocol.
- BMI > 34 kg/m2.
- history of chronic pain.
- history of narcotics or alcohol abuse.
- allergic to NSAID.
- diagnosed as diabetes mellitus with poor glycemic control.
- diagnosed with severe cardiovascular or respiratory diseases.
- judged as an unsuitable subject by investigators.
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. The mean absorption time for the complete release of DS into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. Patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. Post-UPPP pain managing should be cautiously arranged and executed. We hypothesize that the combination of our routine practice and DS will improve the outcomes after Uppp.
Read the detailed description
Within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. After written informed consent gained, the eligibilities are checked. Eligible patients are arrogated into experimental or control group randomly prior to surgery. Experimental group receives the DS administration at least 12 hours before surgery. During peri-operative period, pain management are conducted following our routine practice. Pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.
- Being tested
- Dinalbuphine sebacate, Routine practice
- Keywords
- dinalbuphine sebacte, nalbuphine, Naldebain, Uvulopalatopharyngoplasty
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinalbuphine sebacateDrug
Also called Naldebain
A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
Routine practiceOther
Within 3 days after surgery, paracoxib will be administrated twice a day. Ketorolac will intravenously give once breakthrough pain occurring. Enteral acetaminophen will be take regularly within 14 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Subjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice. Receives: Drug: Dinalbuphine sebacate; Other: Routine practice |
| Control group | Sham comparator | The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration. Receives: Other: Routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
Measured: within 3 days after surgery
Secondary outcomes (8)
Pain intensity
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
Measured: within 14 days after surgery
Consumption of analgesics
Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
Measured: within 3 days after surgery
Consumption of analgesics
Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
Measured: within 14 days after surgery
Percentage of patients consuming analgesics
Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated.
Measured: within 3 days after surgery
Incidence of adverse events
Percentage and number of patients suffering from adverse events will be summarized by the individual days.
Measured: within 3 days after surgery
Incidence of adverse events
Percentage and number of patients suffering from adverse events will be summarized by the individual days.
Measured: within 14 days after surgery
EAT-10 (Eating Assessment Tool)
EAT-10 is a dysphagia assessment that helps to measure swallowing difficulties. There are 10 questions in the questionnaire. Each question has 5 levels, 0 means no problem and 4 means severe problem.
Measured: 1 day, 3 days, 7 days and 14 days after surgery
MD Anderson Dysphagia Inventory
The MDADI is the first validated and reliable self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer. There are 20 questions in the questionnaire. Each question has five levels, including strongly disagree, disagree, no opinion, agree, strongly agree.
Measured: 1 day, 3 days, 7 days and 14 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 posted24 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion23 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-Jen Hsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-Jen Hsin, Chang Gung Memorial Hospital
- Investigators
- Li-Jen Hsin, MD, Principal investigator, Linkou Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825495
- Sponsor's protocol ID
- 202202344A3
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
- ClinicalTrials.gov ID
- NCT05825495
- Acronym / sponsor ID
- 202202344A3
- Keywords
- dinalbuphine sebacte, nalbuphine, Naldebain, Uvulopalatopharyngoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Li-Jen HsinUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 24 Apr 2023 (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 randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. The mean absorption time for the complete release of DS into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. Patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. Post-UPPP pain managing should be cautiously arranged and executed. We hypothesize that the combination of our routine practice and DS will improve the outcomes after Uppp.
Detailed description
Within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. After written informed consent gained, the eligibilities are checked. Eligible patients are arrogated into experimental or control group randomly prior to surgery. Experimental group receives the DS administration at least 12 hours before surgery. During peri-operative period, pain management are conducted following our routine practice. Pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Drug: Dinalbuphine sebacate, Other: Routine practiceSubjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice. |
| Control group | Sham comparator | Other: Routine practiceThe pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 20 and 65.
- diagnosed with obstructive sleep apnea.
- arranged to undergo uvulopalatopharyngoplasty.
- classified as ASA I, II, or III.
Key exclusion criteria (8 listed)
- can not comply with study protocol.
- BMI > 34 kg/m2.
- history of chronic pain.
- history of narcotics or alcohol abuse.
- allergic to NSAID.
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 |
|---|---|---|
| Dinalbuphine sebacateAlso: NaldebainA single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery. | Drug | Experimental group |
| Routine practiceWithin 3 days after surgery, paracoxib will be administrated twice a day. Ketorolac will intravenously give once breakthrough pain occurring. Enteral acetaminophen will be take regularly within 14 days after surgery. | Other | Control group, Experimental group |
Primary outcome
Pain intensity
Time frame: within 3 days after surgery
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
8 secondary outcomes
Pain intensity
Time frame: within 14 days after surgery
Consumption of analgesics
Time frame: within 3 days after surgery
Consumption of analgesics
Time frame: within 14 days after surgery
Percentage of patients consuming analgesics
Time frame: within 3 days after surgery
Incidence of adverse events
Time frame: within 3 days after surgery
Incidence of adverse events
Time frame: within 14 days after surgery
EAT-10 (Eating Assessment Tool)
Time frame: 1 day, 3 days, 7 days and 14 days after surgery
MD Anderson Dysphagia Inventory
Time frame: 1 day, 3 days, 7 days and 14 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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.
Li-Jen Hsin, MD principal investigator
Linkou Chang Gung Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinalbuphine sebacate and Routine practice in people with Pain, Postoperative and Obstructive Sleep Apnea-hypopnea Syndrome, run by Li-Jen Hsin.
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 8 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li-Jen Hsin, MD (886-3-3281200 ext. 8466, lijen.hsin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: within 3 days 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 25 Apr 2023.