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Not yet recruitingNCT07097038Updated Jul 31, 2025

Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

An interventional study of Oliceridine and Oxycodone in Vitrectomy, sponsored by Henan Provincial People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Henan Provincial People's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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).

02

Conditions studied

  • Vitrectomy

Keywords

  • Basic anesthesia
03

In context

Lead sponsor

Henan Provincial People's Hospital is the lead sponsor of 63 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Oliceridine group

    Intraoperative analgesia: Oliceridine 0.015mg/kg

    Drug: Oliceridine

  • Active comparator
    Oxycodone group

    Intraoperative analgesia oxycodone 0.04mg/kg

    Drug: Oxycodone

Interventions

  • DrugOliceridine

    Intraoperative analgesia should be administered with Oliceridine

  • DrugOxycodone

    Oxycodone is used for intraoperative analgesia

06

What researchers measure

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)

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

Secondary outcomes

  1. Adverse reactions

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07097038
Lead sponsor
Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
Jul 31, 2025
Start date
Jul 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jul 31, 2025

Study contacts

Ningning Fu
Contact
736508728@qq.com
8618790658707

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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