Obstructive Sleep Apnea-hypopnea Syndrome, Pain, Acute, Pain, Postoperative
Conditions
Keywords
dinalbuphine sebacte, nalbuphine, Naldebain, Uvulopalatopharyngoplasty
Brief 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. 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.
Interventions
A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
OTHERRoutine practice
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.
Sponsors
Li-Jen Hsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of analgesics | within 3 days after surgery | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. |
| Percentage of patients consuming analgesics | within 3 days after surgery | Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated. |
| Pain intensity | within 14 days after surgery | Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged. |
| EAT-10 (Eating Assessment Tool) | 1 day, 3 days, 7 days and 14 days after surgery | 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. |
| MD Anderson Dysphagia Inventory | 1 day, 3 days, 7 days and 14 days after surgery | 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. |
| Incidence of adverse events | within 3 days after surgery | Percentage and number of patients suffering from adverse events will be summarized by the individual days. |
Contacts
Primary ContactLi-Jen Hsin, MD
Outcome results
None listed