NCT05825495

Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Li-Jen Hsin · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-04-23
• Completion: 2024-05-01
• First posted: 2023-04-24
• Last updated: 2023-04-25