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NCT Number: NCT07097038

Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

a total of 120 patients scheduled for vitrectomy were randomly divided into Oliceridine group (n = 60) and oxycodone group (n = 60). The main outcome measure was visual analogue scale (VAS) at 2 hours after operation, and the secondary outcome measures included intraoperative analgesic drug addition, VAS scores at 6 and 24 hours after operation, respiratory depression (oxygen saturation < 90%) and incidence of adverse reactions (nausea, vomiting, dizziness).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Oliceridine

Drug

Intraoperative analgesia should be administered with Oliceridine

Oxycodone

Drug

Oxycodone is used for intraoperative analgesia

Primary outcomes

  1. VAS score 2 hours after operation

    Time frame: From enrollment to the end of treatment at 1 day

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

Secondary outcomes

  1. Adverse reactions

    Time frame: From enrollment to the end of treatment at 1 day

    ncidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia

Study contacts

Contact information is provided by the study sponsor or research team.

Ningning Fu

CONTACT

[email protected]

8618790658707

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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