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Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery

The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02059694
Enrollment
0
Registered
2014-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2014-12-19

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

Conditions

Upper Eyelid Surgery

Keywords

Eyelid surgery, local block/anesthesia, hyaluronidase, Bilateral upper eyelid surgery, Duke Eye Centre, Duke Aesthetic Center

Brief summary

To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.

Detailed description

Subjects scheduled for bilateral upper eyelid surgery will be recruited from among the patients of the Duke Eye Center. After consent is obtained following full explanation of the research, subjects will be randomly assigned (1:1 ratio) on the day of the surgery to receive local anaesthesia by either with recombinant hyaluronidase (rHuPH20) or without it. Approximately 2 ml of prepared block will be infiltrated in both upper eyelids. Dilutions (Blocks): A) 0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml B) 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20 Test preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon. A Pinprick pain test will be perform 5 minutes after each injection using a sterile finger stick needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe). An average pain score will be calculated for each eyelid. This will help determine if one of the 2 dilutions have a faster anaesthetic effect. Patients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.

Interventions

OTHER2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria: * Capable and willing to provide consent * Has been scheduled for bilateral upper eyelid surgery * At least 18 years of age *

Exclusion criteria

* Unable or unwilling to give consent * Previous upper eyelid surgery * Under 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Pain sensation5 minutes after injectionTest preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon. A second investigator (masked to the treatment condition of each eye) will test Pinprick pain Sensation 5 minutes after each injection using a sterile finger stick needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe).

Secondary

MeasureTime frameDescription
Anesthesia durationAfter procedure startedPatients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026