Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery
NCT ID: NCT02059694
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Hyaluronidase
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
Hyaluronidase
Comparitor
2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20
2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20
Interventions
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Hyaluronidase
2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been scheduled for bilateral upper eyelid surgery
* At least 18 years of age
Exclusion Criteria
* Previous upper eyelid surgery
* Under 18 years of age
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke Eye Center
Durham, North Carolina, United States
Countries
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References
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Roberts MA, Mendez U, Gilbert RJ, Keim AP, Goldman J. Increased hyaluronan expression at distinct time points in acute lymphedema. Lymphat Res Biol. 2012 Sep;10(3):122-8. doi: 10.1089/lrb.2012.0001.
Rowlett J. Extravasation of contrast media managed with recombinant human hyaluronidase. Am J Emerg Med. 2012 Nov;30(9):2102.e1-3. doi: 10.1016/j.ajem.2012.03.005. Epub 2012 May 23.
Clark LE, Mellette JR Jr. The use of hyaluronidase as an adjunct to surgical procedures. J Dermatol Surg Oncol. 1994 Dec;20(12):842-4. doi: 10.1111/j.1524-4725.1994.tb03718.x.
Wohlrab J, Finke R, Franke WG, Wohlrab A. Efficacy study of hyaluronidase as a diffusion promoter for lidocaine in infiltration analgesia of skin. Plast Reconstr Surg. 2012 Apr;129(4):771e-772e. doi: 10.1097/PRS.0b013e318245ea27. No abstract available.
Kallio H, Paloheimo M, Maunuksela EL. Hyaluronidase as an adjuvant in bupivacaine-lidocaine mixture for retrobulbar/peribulbar block. Anesth Analg. 2000 Oct;91(4):934-7. doi: 10.1097/00000539-200010000-00031.
Nathan N, Benrhaiem M, Lotfi H, Debord J, Rigaud G, Lachatre G, Adenis JP, Feiss P. The role of hyaluronidase on lidocaine and bupivacaine pharmacokinetics after peribulbar blockade. Anesth Analg. 1996 May;82(5):1060-4. doi: 10.1097/00000539-199605000-00032.
Other Identifiers
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Pro00051289
Identifier Type: -
Identifier Source: org_study_id