Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Conditions
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Pain, Postoperative, Obstructive Sleep Apnea-hypopnea Syndrome, Pain, Acute

Intervention / Treatment
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* Drug: Dinalbuphine sebacate
* Other: Routine practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>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. | Drug: Dinalbuphine sebacate<br>* A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.<br>* Other names: Naldebain;Other: Routine practice<br>* 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.<br>|
| Sham Comparator: Control group<br>The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration. | Other: Routine practice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. | within 3 days after surgery | 
| Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. | 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. | 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. | 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. | 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. | 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. | 1 day, 3 days, 7 days and 14 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naldebain, Uvulopalatopharyngoplasty, dinalbuphine sebacte, nalbuphine