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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166578
• Other study ID #: 002
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2019
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Cataract
• Eye Diseases
• Ophthalmological Disorder

Intervention

Drug:
• 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

Procedure:
• 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.

Behavioral:
• 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.

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Poland	General Department of Ophthalmology in Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)