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

NCT02059694 | Withdrawn

• 1 other identifier: Pro00051289
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Eyelid Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anesthesia duration

  After procedure started

Study Arms (2)

Hyaluronidase

EXPERIMENTAL

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

Comparitor

OTHER

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

Interventions

Hyaluronidase DRUG

Also known as: 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

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

Comparitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

• 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.

  PMID: 22984909 BACKGROUND

• 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.

  PMID: 22633726 BACKGROUND

• 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.

  PMID: 7798421 BACKGROUND

• 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.

  PMID: 22456420 BACKGROUND

• 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.

  PMID: 11004052 BACKGROUND

• 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.

  PMID: 8610868 BACKGROUND

MeSH Terms

Interventions

Hyaluronoglucosaminidase; Indicator Dilution Techniques; Dental Occlusion; Lidocaine; Epinephrine; Bupivacaine

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Investigative Techniques; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 11, 2014
• Primary Completion: July 1, 2015
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)