Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Versus General Anesthesia

Phase 2Active Not RecruitingNCT07287683

Alexandria University50 enrolled

Overview

Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.

This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases. The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease. This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery. The following measurements will be recorded 1. Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery. 2. Need for analgesic intake after surgery will be assessed for the first 48 hours 3. Complications after surgery as irritation, infection ,and foreign body sensation were assessed 4. Patient satisfaction will be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Topical Anaesthesia General Anesthetic Drug Adverse Reaction Cataract

Interventions

Topical Anaesthesia groupDRUG

This group of patients will only receive topical anaesthesia for Cataract surgery

General Anaesthesia groupDRUG

General Anaesthesia will be given to this group undergoing cataract surgery

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patients with unilateral cataract planned for surgery under topical or general anesthesia Exclusion Criteria: * patients under 20 or over 70 years old Eye infection Patient refusal

Locations (1)

Faculty of Medicine

Alexandria, Egypt

Outcomes

Primary Outcomes

Post operative pain

Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: At 24 hours, one week and 6 weeks following surgery

Secondary Outcomes

1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).

Complications including hypotension, nausea and allergic reaction will be assessed after surgery and 24 hours later. satisfaction assessment will evaluate patient safety, pain control, comfort, nausea, interaction with the surgical team, willingness to repeat the anaesthetic, and relaxation during and after surgery. Patient satisfaction will be recorded at one week and six weeks postoperatively.

Time frame: Up to 6 weeks

Data from ClinicalTrials.gov

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