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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05825495
Other study ID # 202202344A3
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2024

Study information

Verified date April 2023
Source Chang Gung Memorial Hospital
Contact Li-Jen Hsin, MD
Phone 886-3-3281200
Email lijen.hsin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dinalbuphine sebacate
A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
Other:
Routine 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Li-Jen Hsin

Outcome

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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