Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Pain, Postoperative Clinical Trial

Official title:

Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05825495
• Other study ID #: 202202344A3
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

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

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