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

Completed

• Conditions: Cataract; Ophthalmological Disorder; Analgesia
• Interventions: 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

• Registration Number: NCT04166578
• Lead Sponsor: Medical University of Lublin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-31
• Study First Submitted: 2019-08-13
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Study First Posted: 2019-11-18
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mydrane group	Phacoemulsyfication	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.
Mydrane group	Intraocular lens implantation	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.
Mydrane group	Visual Analog Scale for Pain	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.
Mydrane group	Brief Pain Inventory-short form	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.
Mydrane group	Best corrected visual acuity measurment	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.
Mydrane group	Slit-lamp biomicroscopy	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.
Reference group	lignocaine	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.
Reference group	Phacoemulsyfication	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.
Reference group	Intraocular lens implantation	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.
Reference group	Visual Analog Scale for Pain	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.
Reference group	Brief Pain Inventory-short form	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.
Reference group	Best corrected visual acuity measurment	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.
Reference group	Slit-lamp biomicroscopy	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.
Mydrane group	lignocaine	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.

Primary Outcome Measures

Name	Time	Method
The mean pain score measured with VAS Pain	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.
The range of pain was measured on the next day after surgery with BPI-short	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.

Trial Locations

Locations (1)

General Department of Ophthalmology in Lublin; 🇵🇱 Lublin, Poland