Clinical trial NCT05825495: Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
Official title: Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Obstructive Sleep Apnea-hypopnea Syndrome
Pain, Acute
Keywords: dinalbuphine sebacte
nalbuphine
Naldebain
Uvulopalatopharyngoplasty
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: within 3 days after surgery
Secondary outcomes:
measure: Pain intensity
timeFrame: within 14 days after surgery
measure: Consumption of analgesics
timeFrame: within 3 days after surgery
measure: Consumption of analgesics
timeFrame: within 14 days after surgery
measure: Percentage of patients consuming analgesics
timeFrame: within 3 days after surgery
measure: Incidence of adverse events
timeFrame: within 3 days after surgery
measure: Incidence of adverse events
timeFrame: within 14 days after surgery
measure: EAT-10 (Eating Assessment Tool)
timeFrame: 1 day, 3 days, 7 days and 14 days after surgery
measure: MD Anderson Dysphagia Inventory
timeFrame: 1 day, 3 days, 7 days and 14 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Linkou Chang Gung Hospital
name: Li-Jen Hsin, MD
role: PRINCIPAL_INVESTIGATOR
References: