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

NCT04166578 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Analgesia; Ophthalmological Disorder

Outcome Measures

Primary Outcomes (3)

• The mean pain score measured with VAS Pain

  The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.

  preoperatively

• The mean pain score measured with VAS Pain

  The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.

  postoperatively (the next day after surgery- 24 hours)

• The range of pain was measured on the next day after surgery with BPI-short

  The the mean severity score, the pain interference mean score was measured with Brief Pain Inventory-short form (BPI-short form). BPI is one of the most widely used measurement tools for assessing clinical pain. It contains two domains that measure pain intensity (severity) and the impact of pain on functioning (interference). In the current study, BPI was used to evaluate the severity of pain and the impact of pain on daily function in the previous 24 h. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.

  the next day after surgery (24 hours)

Study Arms (2)

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.

Drug: lignocaine; Procedure: Phacoemulsyfication; Procedure: Intraocular lens implantation; Behavioral: Visual Analog Scale for Pain; Behavioral: Brief Pain Inventory-short form; Diagnostic Test: Best corrected visual acuity measurment; Diagnostic Test: Slit-lamp biomicroscopy

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.

Drug: lignocaine; Procedure: Phacoemulsyfication; Procedure: Intraocular lens implantation; Behavioral: Visual Analog Scale for Pain; Behavioral: Brief Pain Inventory-short form; Diagnostic Test: Best corrected visual acuity measurment; Diagnostic Test: Slit-lamp biomicroscopy

Interventions

lignocaine 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

Mydrane group; Reference group

Phacoemulsyfication 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.

Mydrane group; Reference group

Intraocular lens implantation 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.

Mydrane group; Reference group

Visual Analog Scale for Pain BEHAVIORAL

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

Also known as: VAS for pain

Mydrane group; Reference group

Brief Pain Inventory-short form 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.

Also known as: BPI short form

Mydrane group; Reference group

Best corrected visual acuity measurment 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.

Also known as: BCVA

Mydrane group; Reference group

Slit-lamp biomicroscopy DIAGNOSTIC_TEST

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

Mydrane group; Reference group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 70 patients was initially scheduled to participate in this study. However, 8 patients did not attend the postoperative visits and were excluded. As a result, only 62 patients were included in the analysis. The mean age (±SD) of patients was 73.95 (±7.82) years. Female to male ratio was 55/45 in Mydrane group and 53/47 in the control group.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

General Department of Ophthalmology in Lublin

Lublin, 20-001, Poland

Location

MeSH Terms

Conditions

Cataract; Agnosia; Eye Diseases

Interventions

Lidocaine; Lens Implantation, Intraocular; Slit Lamp Microscopy

Condition Hierarchy (Ancestors)

Lens Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: November 18, 2019
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: July 31, 2017
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)