Proliferative Diabetic Retinopathy
Conditions
Keywords
pain management, panretinal photocoagulation, proliferative diabetic retinopathy, peribulbar anesthesia
Brief summary
The purpose of this study was to compare two different anesthesia methods for pain control during panretinal photocoagulation (PRP), a type of laser surgery that treats proliferative diabetic retinopathy (PDR). The study included eyes from patients with diabetes and proliferative diabetic retinopathy who were scheduled to undergo their first PRP session. Participants were split into two groups to receive either peribulbar anesthesia, which is a type of anesthesia injected through the eyelid, or a sham injection with topical anesthesia only. Pain on a numerical scale and vital signs were recorded before and for 15 minutes during PRP. These results were compared between the two groups to determine which method delivers superior pain control.
Interventions
DRUGPeribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine
A mixture of 1.5 mL of 0.5% bupivacaine and 1.5 mL of 2% lidocaine was prepared in a 3 mL syringe. The peribulbar injection was administered using a 25G needle inserted horizontally through the inferior palpebral conjunctiva, directed axially over the infraorbital rim, and then angled upward to deliver the anesthetic into the orbit.
A single drop of topical 5% tetracaine
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older with proliferative diabetic retinopathy * Scheduled to undergo their first PRP session * Able to maintain the required posture at the slit lamp throughout the procedure
Exclusion criteria
* History of phobic anxiety disorder related to needles or injections * Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine * Use of analgesics within 24 hours prior to treatment * Cognitive or motor impairments that could hinder effective communication of pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception during PRP administration | Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye. | patient perception of pain during PRP administration in each eye, measured using the Numerical Rating Scale (NRS). The NRS measures pain intensity on a scale of 0 to 10, where 0 corresponds to the absence of pain and 10 represents the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye. | Heart rate measured as beats per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China) |
| Respiratory rate | at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye. | Respiratory rate measured as breaths per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China) |
| Oxygen saturation | at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye. | Oxygen saturation was measured as SpO2 using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China) |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORJosé Gerardo García Aguirre, MD
Asociación Para Evitar la Ceguera en México, I.A.P.
Outcome results
None listed