Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia
NCT ID: NCT03902925
Last Updated: 2019-11-04
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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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2019-01-01
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1- Sub-tenon plus lidocaine jelly
Patients are going to be submitted to lidocaine 2% jelly topical anesthesia for 5 minutes then to sub-tenon injection of 2-4 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.
Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection
Lidocaine 2% jelly applied to conjunctival fornices for 5 minutes then injection of 2-4 ml of ropivacaine 10% in the sub-tenon space with a blunt cannula through a temporal inferior incision
Group 2- peribulbar
Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.
Peribulbar injection
Peribulbar injection of 4-6 ml of ropivacaine 10%
Interventions
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Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection
Lidocaine 2% jelly applied to conjunctival fornices for 5 minutes then injection of 2-4 ml of ropivacaine 10% in the sub-tenon space with a blunt cannula through a temporal inferior incision
Peribulbar injection
Peribulbar injection of 4-6 ml of ropivacaine 10%
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous scleral buckle surgery
* Uncontrolled arterial hypertension
* Any ocular surgery performed in the studied eye in the previous three months
* Medical or psychological condition that preclude study adherence
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Jefferson Augusto Santana Ribeiro
Principal investigator
Principal Investigators
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Jefferson AS Ribeiro, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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School of Medicine - Clinical Hospital
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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Tang S, Lai P, Lai M, Zou Y, Li J, Li S. Topical anesthesia in transconjunctival sutureless 25-gauge vitrectomy for macular-based disorders. Ophthalmologica. 2007;221(1):65-8. doi: 10.1159/000096526.
Stevens JD, Foss AJ, Hamilton AM. No-needle one-quadrant sub-tenon anaesthesia for panretinal photocoagulation. Eye (Lond). 1993;7 ( Pt 6):768-71. doi: 10.1038/eye.1993.180.
Spaeth G. Ophthalmic Surgery, Principles and Practice. Third Edition. Saunders, Philadelphia, 2003.
Sousa FAEF, Silva JA. Avaliação e mensuração da dor em contextos clínicos e de pesquisa. Rev. Dor, 2004;5(4):408-429.
Roman SJ, Chong Sit DA, Boureau CM, Auclin FX, Ullern MM. Sub-Tenon's anaesthesia: an efficient and safe technique. Br J Ophthalmol. 1997 Aug;81(8):673-6. doi: 10.1136/bjo.81.8.673.
Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x.
Rao GP, Wong D, Groenewald C, McGalliard JN, Jones A, Ridges PJ. Local anaesthesia for vitreoretinal surgery: a case-control study of 200 cases. Eye (Lond). 1998;12 ( Pt 3a):407-11. doi: 10.1038/eye.1998.96.
Theocharis IP, Alexandridou A, Tomic Z. A two-year prospective study comparing lidocaine 2% jelly versus peribulbar anaesthesia for 25G and 23G sutureless vitrectomy. Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1253-8. doi: 10.1007/s00417-007-0556-y. Epub 2007 Mar 7.
Other Identifiers
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ST anesthesia for PPV
Identifier Type: -
Identifier Source: org_study_id
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