Pain, Postoperative Clinical Trial
Official title:
Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
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.
Status | Not yet recruiting |
Enrollment | 78 |
Est. completion date | May 1, 2024 |
Est. primary completion date | April 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - aged between 20 and 65. - diagnosed with obstructive sleep apnea. - arranged to undergo uvulopalatopharyngoplasty. - classified as ASA I, II, or III. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Li-Jen Hsin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged. | within 3 days after surgery | |
Secondary | Pain intensity | Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged. | within 14 days after surgery | |
Secondary | Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. | within 3 days after surgery | |
Secondary | Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. | within 14 days after surgery | |
Secondary | Percentage of patients consuming analgesics | Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated. | within 3 days after surgery | |
Secondary | Incidence of adverse events | Percentage and number of patients suffering from adverse events will be summarized by the individual days. | within 3 days after surgery | |
Secondary | Incidence of adverse events | Percentage and number of patients suffering from adverse events will be summarized by the individual days. | within 14 days after surgery | |
Secondary | 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. | 1 day, 3 days, 7 days and 14 days after surgery | |
Secondary | 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. | 1 day, 3 days, 7 days and 14 days after surgery |
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