NCT05825495

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2023

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 11, 2023

Last Update Submit

April 23, 2023

Conditions

Pain, PostoperativeObstructive Sleep Apnea-hypopnea SyndromePain, Acute

Keywords

dinalbuphine sebactenalbuphineNaldebainUvulopalatopharyngoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Pain intensity

    within 14 days after surgery

  • Consumption of analgesics

    within 3 days after surgery

  • Consumption of analgesics

    within 14 days after surgery

  • Percentage of patients consuming analgesics

    within 3 days after surgery

  • Incidence of adverse events

    within 3 days after surgery

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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 sebacateOther: Routine practice

Control group

SHAM COMPARATOR

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

Other: Routine practice

Interventions

Dinalbuphine sebacateDRUG

A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.

Also known as: Naldebain
Experimental group
Routine practiceOTHER

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.

Control groupExperimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 20 and 65.
  • diagnosed with obstructive sleep apnea.
  • arranged to undergo uvulopalatopharyngoplasty.
  • classified as ASA I, II, or III.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Li-Jen Hsin, MD

    Linkou Chang Gung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Jen Hsin, MD

CONTACT

886-3-3281200lijen.hsin@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

May 1, 2023

Primary Completion

April 23, 2024

Study Completion

May 1, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04