Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03902925

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Disease Diabetic Retinopathy Maculopathy	Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection Procedure: Peribulbar injection	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Active Comparator: 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.	Procedure: Peribulbar injection Peribulbar injection of 4-6 ml of ropivacaine 10%

Arm

Intervention/Treatment

Experimental: 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.

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

Active Comparator: 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.

Procedure: Peribulbar injection

Peribulbar injection of 4-6 ml of ropivacaine 10%

Outcome Measures

Primary Outcome Measures

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

Surgical complications [Once At the end of vitrectomy surgery]
Surgical complications referred by the surgeon during vitrectomy

Other Outcome Measures

Duration of surgery [Once At the end of vitrectomy surgery]
Duration of vitrectomy in minutes
Anesthetic medications [Once during the vitrectomy surgery]
Other anesthetic medication for controlling pain administered during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.