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Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dinalbuphine sebacate
Routine practice
Sponsored by
Li-Jen Hsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring dinalbuphine sebacte, nalbuphine, Naldebain, Uvulopalatopharyngoplasty

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    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.

    The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration.

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.

    Secondary Outcome Measures

    Pain intensity
    Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
    Consumption of analgesics
    Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
    Consumption of analgesics
    Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
    Percentage of patients consuming analgesics
    Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated.
    Incidence of adverse events
    Percentage and number of patients suffering from adverse events will be summarized by the individual days.
    Incidence of adverse events
    Percentage and number of patients suffering from adverse events will be summarized by the individual days.
    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.
    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.

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    April 23, 2023
    Sponsor
    Li-Jen Hsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05825495
    Brief Title
    Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
    Official Title
    Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    April 23, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Li-Jen Hsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Obstructive Sleep Apnea-hypopnea Syndrome, Pain, Acute
    Keywords
    dinalbuphine sebacte, nalbuphine, Naldebain, Uvulopalatopharyngoplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Dinalbuphine sebacate
    Other Intervention Name(s)
    Naldebain
    Intervention Description
    A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
    Intervention Type
    Other
    Intervention Name(s)
    Routine practice
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
    Time Frame
    within 3 days after surgery
    Secondary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
    Time Frame
    within 14 days after surgery
    Title
    Consumption of analgesics
    Description
    Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
    Time Frame
    within 3 days after surgery
    Title
    Consumption of analgesics
    Description
    Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
    Time Frame
    within 14 days after surgery
    Title
    Percentage of patients consuming analgesics
    Description
    Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated.
    Time Frame
    within 3 days after surgery
    Title
    Incidence of adverse events
    Description
    Percentage and number of patients suffering from adverse events will be summarized by the individual days.
    Time Frame
    within 3 days after surgery
    Title
    Incidence of adverse events
    Description
    Percentage and number of patients suffering from adverse events will be summarized by the individual days.
    Time Frame
    within 14 days after surgery
    Title
    EAT-10 (Eating Assessment Tool)
    Description
    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.
    Time Frame
    1 day, 3 days, 7 days and 14 days after surgery
    Title
    MD Anderson Dysphagia Inventory
    Description
    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.
    Time Frame
    1 day, 3 days, 7 days and 14 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li-Jen Hsin, MD
    Phone
    886-3-3281200
    Ext
    8466
    Email
    lijen.hsin@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li-Jen Hsin, MD
    Organizational Affiliation
    Linkou Chang Gung Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

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