Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

University of Sao Paulo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Maculopathy; Retinal Disease; Diabetic Retinopathy

Treatments: Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection; Procedure: Peribulbar injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03902925

ST anesthesia for PPV

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Group 1- Sub-tenon plus lidocaine jelly

Experimental group

Description:

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.

Treatment:

Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection

Group 2- peribulbar

Active Comparator group

Description:

Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.

Treatment:

Procedure: Peribulbar injection