Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

Li-Jen Hsin

Status and phase: Not yet enrolling; Phase 4

Conditions: Obstructive Sleep Apnea-hypopnea Syndrome; Pain, Acute; Pain, Postoperative

Treatments: Drug: Dinalbuphine sebacate; Other: Routine practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05825495

202202344A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Experimental group

Active Comparator group

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.

Treatment:

Drug: Dinalbuphine sebacate

Other: Routine practice

Control group

Sham Comparator group

Description:

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

Treatment:

Other: Routine practice