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NCT Number: NCT04166578

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

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.

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Key information

Conditions

Cataract Agnosia Analgesia Eye Diseases Lens Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Ophthalmological Disorder Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Department of Ophthalmology in Lublin

Lublin, 20-001, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

Visual Analog Scale for Pain

Behavioral

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

Other names: VAS for pain

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.

Other names: BPI short form

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.

Other names: BCVA

Slit-lamp biomicroscopy

Diagnostic Test

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

Primary outcomes

  1. The mean pain score measured with VAS Pain

    Time frame: preoperatively

    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.

  2. The mean pain score measured with VAS Pain

    Time frame: postoperatively (the next day after surgery- 24 hours)

    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.

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

    Time frame: the next day after surgery (24 hours)

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Comparison of Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery: a Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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