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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Pain, Acute; Obstructive Sleep Apnea-hypopnea Syndrome
• Intervention / Treatment: Drug: Dinalbuphine sebacate; Other: Routine practice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li-Jen Hsin, MD; Phone Number: 8466 886-3-3281200; Email: lijen.hsin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Li-Jen Hsin
• Investigators: Principal Investigator: Li-Jen Hsin, MD, Linkou Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): April 23, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: nalbuphine; Naldebain; Uvulopalatopharyngoplasty; dinalbuphine sebacte
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: 202202344A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No