Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery in Patients
NCT ID: NCT04166578
Last Updated: 2019-11-18
Study Results
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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COMPLETED
62 participants
OBSERVATIONAL
2017-01-01
2017-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
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
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
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
VAS for Pain is a new tool developed to assess the pain in quantitative terms.
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.
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.
Slit-lamp biomicroscopy
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
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
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
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
VAS for Pain is a new tool developed to assess the pain in quantitative terms.
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.
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.
Slit-lamp biomicroscopy
Slit-lamp biomicroscopy allows study of ocular structures and their relationships.
Interventions
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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
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.
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.
Visual Analog Scale for Pain
VAS for Pain is a new tool developed to assess the pain in quantitative terms.
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.
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.
Slit-lamp biomicroscopy
Slit-lamp biomicroscopy allows study of ocular structures and their relationships.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* best corrected visual acuity (BCVA) of 0.2 logMAR or worse
* and agreement for taking part in the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of Lublin
OTHER
Responsible Party
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Locations
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General Department of Ophthalmology in Lublin
Lublin, , Poland
Countries
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Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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