Upper Eyelid Surgery Clinical Trial
Official title:
The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery
To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment