Diabetic Retinopathy, Maculopathy, Retinal Disease
Conditions
Keywords
vitrectomy, anesthesia, retinal disease, Pain, diabetic retinopathy, maculopathy
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.
Interventions
PROCEDURETopical 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
PROCEDUREPeribulbar injection
Peribulbar injection of 4-6 ml of ropivacaine 10%
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | Once At the end of vitrectomy surgery | Surgical complications referred by the surgeon during vitrectomy |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed