Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

NCT ID: NCT05825495

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

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.

Group Type: ACTIVE_COMPARATOR

Dinalbuphine sebacate

Intervention Type: DRUG

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

Routine practice

Intervention Type: OTHER

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 group

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

Group Type: SHAM_COMPARATOR

Routine practice

Intervention Type: OTHER

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.

Interventions

Dinalbuphine sebacate

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Naldebain

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li-Jen Hsin

OTHER

Sponsor Role: lead

Responsible Party

Li-Jen Hsin

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Li-Jen Hsin, MD

Role: PRINCIPAL_INVESTIGATOR

Linkou Chang Gung Hospital

Central Contacts

Li-Jen Hsin, MD

Role: CONTACT

lijen.hsin@gmail.com

886-3-3281200 ext. 8466

Other Identifiers

202202344A3

Identifier Type: -

Identifier Source: org_study_id