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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Upper Eyelid Surgery

Intervention / Treatment
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* Drug: Hyaluronidase
* Other: 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronidase<br>Dilutions (Blocks): 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 | Drug: Hyaluronidase<br> <br> * Other names: 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;|
| Other: Comparitor<br>2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20 | Other: 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation | 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 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). | 5 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia duration | 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. | After procedure started | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eyelid surgery, local block/anesthesia, hyaluronidase, Bilateral upper eyelid surgery, Duke Eye Centre, Duke Aesthetic Center