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

NCT ID: NCT07287683

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2026-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Topical Anaesthesia General Anesthetic Drug Adverse Reaction Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group under general anesthesia for cataract surgery

Patients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics

Group Type ACTIVE_COMPARATOR

General Anaesthesia group

Intervention Type DRUG

General Anaesthesia will be given to this group undergoing cataract surgery

Group under topical anaesthesia

Patients will receive topical anaesthesia for cataract surgery

Group Type ACTIVE_COMPARATOR

Topical Anaesthesia group

Intervention Type DRUG

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

Interventions

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Topical Anaesthesia group

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

Intervention Type DRUG

General Anaesthesia group

General Anaesthesia will be given to this group undergoing cataract surgery

Intervention Type DRUG

Other Intervention Names

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Topical group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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radwa saber

Dr. Radwa Saber, lecturer of Anesthesiology, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Radwa S Raslan, PHD

Role: PRINCIPAL_INVESTIGATOR

AMUH

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0307211

Identifier Type: -

Identifier Source: org_study_id