Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

NCT07097038 | Not Yet Recruiting DMC

• 1 other identifier: HenanPPH-FNN2
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traditional opioid analgesia is a method to treat moderate to severe pain. However, the use of opioids is not without risks. When treating acute pain, patients may have hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability and pruritus. The aim of this study was to evaluate the analgesic effect and safety of g-protein-biased μ - opioid receptor agonists Oliceridine and oxycodone in vitrectomy.

Conditions

Vitrectomy

Keywords

Basic anesthesia

Outcome Measures

Primary Outcomes (1)

• VAS score 2 hours after operation

  Postoperative 2-hour VAS score (total score of 10, 0 indicates no pain, and 10 indicates the most severe unbearable pain)

  From enrollment to the end of treatment at 1 day

Secondary Outcomes (1)

• Adverse reactions

  From enrollment to the end of treatment at 1 day

Study Arms (2)

Oliceridine group

EXPERIMENTAL

Intraoperative analgesia: Oliceridine 0.015mg/kg

Drug: Oliceridine

Oxycodone group

ACTIVE COMPARATOR

Intraoperative analgesia oxycodone 0.04mg/kg

Drug: Oxycodone

Interventions

Oliceridine DRUG

Intraoperative analgesia should be administered with Oliceridine

Oliceridine group

Oxycodone DRUG

Oxycodone is used for intraoperative analgesia

Oxycodone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, ASA Ⅰ - Ⅱ (the age of patients with vitreous surgery can be relaxed to 75 years old, and serious systemic diseases need to be excluded);
• Vitrectomy with local anesthesia (retrobulbar / peribulbar block) combined with intravenous sedation and analgesia (such as maculopathy, retinal detachment, etc.);
• Preoperative VAS score ≤ 3, can cooperate with pain and sedation score;
• Signed informed consent.

You may not qualify if:

• Be allergic to test drugs or opioids, or have a history of opioid abuse;
• Severe cardiopulmonary disease (such as heart failure, COPD), liver and kidney dysfunction (alt/ast \> 3 times normal, creatinine \> 177 μ mol/l);
• Glaucoma (avoiding the risk of fluctuation of intraocular pressure), sinus bradycardia (\< 50 beats / min, preventing aggravation of oculo cardiac reflex);
• Used analgesic / sedative drugs within 24 hours before surgery;
• Those who are unable to cooperate due to mental illness or cognitive impairment.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Ningning Fu

CONTACT

8618790658707; 736508728@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 31, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share