Topical and subconjunctival anesthesia versus topical anesthesia alone in patients with senile cataracts undergoing phacoemulsification: a double-blind randomized controlled trail

Phase 4

Completed

• Conditions: cataract; phacoemulsification; anesthesia

• Registration Number: TCTR20220804003
• Lead Sponsor: Sawanpracharak Hospital

Brief Summary

The addition of subconjunctival lidocaine injection to topical anesthesia reduced postoperative pain and improved patient cooperation during phacoemulsification. However, the lidocaine injection was painful, and it carried a higher risk of spontaneous-relief subconjunctival hemorrhage.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-04
• Study Completion: 2022-12-12
• Results First Posted: 2024-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Patient with cataract surgery (Phacoemulsification) at Sawanparcharak Hospital (same surgeon)

Exclusion Criteria

1. cataract patient with Pseudoexfoliation syndrome, lens subluxation, posterior polar cataract, poor pupil dilation or posterior synechiae
2. Any additional operation being performed simultaneously, (e.g., pterygium excision, trabeculectomy, goniosynechialysis, lysis posterior synechiae)
3. Patients with communication difficulties, dementia, mental retardation, deafness
4. Uncooperative patient during slit lamp examination
5. Need for extracapsular cataract extraction or intracapsular cataract extraction
6. Allergy to topical and subconjunctival anesthesia
7. patient with medical conditions or postural deformities preventing appropriate head position while lying on operative table
8. patient refuse to participate in research
9. Neurological problems which impede the surgery, e.g., nystagmus, pakinson

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score immediate after surgery numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Patient co- operation during surgery patient co-operative score (assess by surgeon),complications from subconjunctival injection during surgery data extraction from medical record,complications from phacoemulsification during surgery data extraction from medical record,Operative time during surgery (from insert eye speculum to remove eye speculum) data extraction from medical record,Pain score before subconjunctival injection, after subconjunctival injection, 2 hours after surgery, when patient complain about pain and ask for more topical anesthesia during surgery numeric rating scale