Clinical trial NCT03902925: Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia
Official title: Pain During Pars Plana Vitrectomy Comparing Peribulbar Anesthesia Versus Sub-tenon Injection Plus Topical Jelly Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retinal Disease
Diabetic Retinopathy
Maculopathy
Keywords: vitrectomy
anesthesia
retinal disease
Pain
diabetic retinopathy
maculopathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitreoretinal surgery has evolved to less invasive procedures, and it is used to treat a wide range of diseases. So anesthesia for vitreoretinal procedures has evolved, promoting adequate analgesia while reducing risks to the patient. In the present study two types of procedures for anesthesia during vitreoretinal surgery are evaluated regarding the pain referred by the patient during the whole procedure: peribulbar anesthesia versus sub-tenon injection plus topical jelly anesthesia. Through the comparative analysis of the pain scale of the two groups it is expected that the two modalities present the same anesthetic efficacy, showing that the methods used may be equivalent.


Eligibility criteria: Inclusion Criteria:

* Patients that have the diagnosis of epiretinal membrane, macular hole, complication of diabetic retinopathy such as vitreous hemorrhage or traction retinal detachment or other vitreomacular diseases that require treatment by pars plana vitrectomy.

Exclusion Criteria:

* Previous pars plana vitrectomy in the studied eye.
* 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

Primary outcomes:
measure: Pain score
timeFrame: Once 30 minutes after the end of the vitrectomy surgery
Secondary outcomes:
measure: Surgical complications
timeFrame: Once At the end of vitrectomy surgery
Other outcomes:
measure: Duration of surgery
timeFrame: Once At the end of vitrectomy surgery
measure: Anesthetic medications
timeFrame: Once during the vitrectomy surgery
Locations:
city: Ribeirao Preto
country: Brazil
facility: School of Medicine - Clinical Hospital
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Jefferson AS Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.