Upper Eyelid Surgery Clinical Trial
Official title:
The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery
| NCT number | NCT02059694 |
| Other study ID # | Pro00051289 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | February 10, 2014 |
| Last updated | December 18, 2014 |
| Verified date | December 2014 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
- 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke Eye Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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-2e. doi: 10.1097/PRS.0b013e318245ea27. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |