Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Phase 1

Completed

• Conditions: Diabetic Retinopathy; Maculopathy; Retinal Disease
• Interventions: Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection; Procedure: Peribulbar injection

• Registration Number: NCT03902925
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2019-08-31
• Status Verified: 2019-10
• Study Completion: 2019-10-31
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1- Sub-tenon plus lidocaine jelly	Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection	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.
Group 2- peribulbar	Peribulbar injection	Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.

Primary Outcome Measures

Name	Time	Method
Pain score	Once 30 minutes after the end of the vitrectomy surgery	Pain score referred by the patient measured with a Visual Analogue Scale (VAS). The VAS consists of ruler with 100 cm in length and scale from 0 to 100, where the numbers of this one are visible only in the side of the examiner. It is constructed from a metal ruler with a total length of one meter, supported by two transparent acrylic side supports and a sliding and movable metal weight on the metallic part of the ruler.; Before the measurement of pain, the examiner will explain to the patients the functioning of the VAS. Each patient will be encouraged to pass the marker along the scale, with the help of the examiner. It will be made clear to him that point "0" is the point of the scale which represented "no pain", what is considered the better outcome, and point "100" corresponded to the most intense pain he could feel. The patient will be asked about: Intraoperative pain - the intensity of pain throughout the procedure.

Secondary Outcome Measures

Name	Time	Method
Surgical complications	Once At the end of vitrectomy surgery	Surgical complications referred by the surgeon during vitrectomy

Trial Locations

Locations (1)

School of Medicine - Clinical Hospital; 🇧🇷 Ribeirao Preto, SP, Brazil