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Evaluation of the anesthetic effect of mixtures of local anesthetics and Tergase® in ophthalmic regional anesthesia

Evaluation of the anesthetic effect of mixtures of local anesthetics and Tergase® in ophthalmic regional anesthesia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0012168
Enrollment
60
Registered
2026-06-24
Start date
2026-06-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : The intervention consists of ophthalmic regional anesthesia using a mixture of local anesthetic agents with or without Tergase®. In the experimental group, patien

Sponsors

Chung-Ang University Gwangmyeong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 80 years. 2) Patients scheduled to undergo ophthalmic surgery requiring retrobulbar anesthesia. 3) Patients who voluntarily provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity or allergic reaction to Tergase® (recombinant human hyaluronidase). 2) Patients at high risk of retrobulbar hemorrhage during retrobulbar anesthesia, including those with an increased bleeding tendency. 3) Pregnant or breastfeeding women. 4) History of previous orbital surgery. 5) Thyroid eye disease (thyroid-associated ophthalmopathy). 6) Endophthalmitis. 7) Patients receiving anticoagulant therapy. 8) Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Time to ocular akinesia after retrobulbar block

Secondary

MeasureTime frame
Time to orbicularis oculi muscle akinesia after Nadbath block;Degree of orbicularis oculi muscle akinesia;Degree of ocular akinesia;Intraocular pressure (IOP) change;Chemosis score;Pain score (Numeric Rating Scale; NRS; 0–10);Use of rescue analgesics;Patient satisfaction;Surgeon satisfaction

Countries

Korea, Republic of

Contacts

Public ContactJin-Ho Joo

Chung-Ang University Gwangmyeong Hospital

oph.jhjoo@gmail.com+82-2-2610-6806

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 3, 2026