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A prospective, randomized, controlled, double-blind clinical trial comparing the efficacy and safety of different local anesthetics in peribulbar anesthesia for vitreoretinal surgery

A prospective, randomized, controlled, double-blind clinical trial comparing the efficacy and safety of different local anesthetics in peribulbar anesthesia for vitreoretinal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111344
Enrollment
Unknown
Registered
2025-10-30
Start date
2024-06-13
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitreoretinopathy

Interventions

Combination Group:A equal volumes combination of1% ropivacaine and 2% lidocaine

Sponsors

Eye Hospital, the First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients undergoing vitreoretinal surgery must simultaneously meet the following criteria: 1. Aged between 18 and 80 years inclusive, of either sex; 2. Subjects diagnosed with diabetic retinopathy, central or branch retinal vein occlusion, retinal detachment, macular retinal disease, silicone oil eye, or other conditions requiring vitreoretinal surgery; 3. Stable vital signs, with ASA physical status classification between Grade I and Grade III. 4. Subjects able to communicate fluently with medical staff; 5. Subjects voluntarily participating in the trial and having signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects with keratitis, anterior uveitis, or uveitis; those with orbital deformities or a history of orbital surgery; patients with ocular trauma, as injection of anaesthetic may cause temporary mild proptosis due to increased orbital pressure, and peribulbar anaesthesia may increase loss of ocular contents, hence such patients must be excluded; individuals with corneal thinning due to corneal dystrophy or other similar conditions unsuitable for peribulbar anaesthesia; 2. ASA physical status classification > Grade III; 3. Patients deemed unsuitable for this study by the investigator, or those judged incapable of completing the study, or those with poor compliance; 4. Known allergy or intolerance to the investigational medicinal product; 5. Pregnant or lactating women; 6. Subjects with a history of active or passive smoking.

Design outcomes

Primary

MeasureTime frame
total anesthetic dose;Time of onset of analgesia;Time of onset of akinesia;

Secondary

MeasureTime frame
Pain scores at 24 hours after surgery;Duration of anesthesia;

Countries

China

Contacts

Public ContactXuhui Yu

Eye Hospital, the First Affiliated Hospital of Harbin Medical University

2893669402@qq.com+86 176 6756 5435

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026