NCT03902925

Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Pain During Pars Plana Vitrectomy Comparing Peribulbar Anesthesia Versus Sub-tenon Injection Plus Topical Jelly Anesthesia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Disease
• Diabetic Retinopathy
• Maculopathy

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	Peribulbar injection	Peribulbar injection of 4-6 ml of ropivacaine 10%

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-08-31
• Completion: 2019-10-31
• First posted: 2019-04-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: Brazil