Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery in Patients

NCT ID: NCT04166578

Last Updated: 2019-11-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities.

Methods: In this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. The analgetic effect of these two anesthetic methods was evaluated using psychological tools - Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract Analgesia Ophthalmological Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mydrane group

Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.

lignocaine

Intervention Type DRUG

The group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic

Phacoemulsyfication

Intervention Type PROCEDURE

Phacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye.

Intraocular lens implantation

Intervention Type PROCEDURE

An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery.

Visual Analog Scale for Pain

Intervention Type BEHAVIORAL

VAS for Pain is a new tool developed to assess the pain in quantitative terms.

Brief Pain Inventory-short form

Intervention Type BEHAVIORAL

BPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function.

Best corrected visual acuity measurment

Intervention Type DIAGNOSTIC_TEST

Measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20.

Slit-lamp biomicroscopy

Intervention Type DIAGNOSTIC_TEST

Slit-lamp biomicroscopy allows study of ocular structures and their relationships.

Reference group

Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.

lignocaine

Intervention Type DRUG

The group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic

Phacoemulsyfication

Intervention Type PROCEDURE

Phacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye.

Intraocular lens implantation

Intervention Type PROCEDURE

An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery.

Visual Analog Scale for Pain

Intervention Type BEHAVIORAL

VAS for Pain is a new tool developed to assess the pain in quantitative terms.

Brief Pain Inventory-short form

Intervention Type BEHAVIORAL

BPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function.

Best corrected visual acuity measurment

Intervention Type DIAGNOSTIC_TEST

Measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20.

Slit-lamp biomicroscopy

Intervention Type DIAGNOSTIC_TEST

Slit-lamp biomicroscopy allows study of ocular structures and their relationships.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lignocaine

The group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic

Intervention Type DRUG

Phacoemulsyfication

Phacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye.

Intervention Type PROCEDURE

Intraocular lens implantation

An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery.

Intervention Type PROCEDURE

Visual Analog Scale for Pain

VAS for Pain is a new tool developed to assess the pain in quantitative terms.

Intervention Type BEHAVIORAL

Brief Pain Inventory-short form

BPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function.

Intervention Type BEHAVIORAL

Best corrected visual acuity measurment

Measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20.

Intervention Type DIAGNOSTIC_TEST

Slit-lamp biomicroscopy

Slit-lamp biomicroscopy allows study of ocular structures and their relationships.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VAS for pain BPI short form BCVA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age above 18 years
* best corrected visual acuity (BCVA) of 0.2 logMAR or worse
* and agreement for taking part in the study

Exclusion Criteria

* depressive disorder or expected compliance problems (known psychiatric disease)
* epilepsy
* ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission
* daily analgesic treatment
* intake of additional rescue medications due to the pain after surgery
* omitting postoperative visit
* no consent to complete the survey
* The patients who later needed additional medications for pain relief
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Department of Ophthalmology in Lublin

Lublin, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remimazolam for Cataract Surgery
NCT05980117 RECRUITING PHASE4