VitrectomyNCT07097038
Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy
A study testing Oliceridine and Oxycodone in people with Vitrectomy, run by Henan Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Oliceridine and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial
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).
- Conditions
- Vitrectomy
- Being tested
- Oliceridine, Oxycodone
- Keywords
- Basic anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Intraoperative analgesia should be administered with Oliceridine
OxycodoneDrug
Oxycodone is used for intraoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine group | Experimental | Intraoperative analgesia: Oliceridine 0.015mg/kg Receives: Drug: Oliceridine |
| Oxycodone group | Active comparator | Intraoperative analgesia oxycodone 0.04mg/kg Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: From enrollment to the end of treatment at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097038
- Sponsor's protocol ID
- HenanPPH-FNN2
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07097038
- Acronym / sponsor ID
- HenanPPH-FNN2
- Conditions
- Vitrectomy
- Keywords
- Basic anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oliceridine group | Experimental | Drug: OliceridineIntraoperative analgesia: Oliceridine 0.015mg/kg |
| Oxycodone group | Active comparator | Drug: OxycodoneIntraoperative analgesia oxycodone 0.04mg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OliceridineIntraoperative analgesia should be administered with Oliceridine | Drug | Oliceridine group |
| OxycodoneOxycodone is used for intraoperative analgesia | Drug | Oxycodone group |
Primary outcome
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)
1 secondary outcome
Adverse reactions
Time frame: From enrollment to the end of treatment at 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oliceridine and Oxycodone in people with Vitrectomy, run by Henan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ningning Fu (8618790658707, 736508728@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score 2 hours after operation (time frame: From enrollment to the end of treatment at 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.