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The effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery under topical anesthesia and sedation

Protocol summary

Study aim
Evaluating the effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery
Design
A randomized single-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 62 patients candidates for cataract surgery will be included and will be randomly divided into two groups. In the control group, only local anesthesia and sedation are performed. But in the intervention group, in addition to local anesthesia, intracameral lidocaine will be injected. Then the pain and hemodynamic parameters of the patients are evaluated.
Participants/Inclusion and exclusion criteria
Patients in the age group of 40 to 80 years, candidates for cataract surgery using phaco-emulsification, under topical anesthesia and sedation, classified as ASA I and ASA II will be included in the study. Patients with a history of opioids abuse, allergy to lidocaine or tetracaine, history of alcohol and psychotropic substance abuse, history of untreated systemic disease and hemodynamic disorder, history of convulsion, pregnancy/breastfeeding, history of mental illness, taking painkillers 24 hours before surgery and body mass index (BMI) of > 35 kg/m2.
Intervention groups
Control group: For patients in this group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. And immediately after corneal incision and before capsulorhexis, four drops of sterile BSS solution are injected into the anterior chamber. Intervention group: For patients in this group, after receiving topical tetracaine drops as in the control group, immediately after corneal incision and before capsulorhexis, four drops of 1% intracameral lidocaine will be injected without preservative.
Main outcome variables
Pain score; heart rate; breath rate; mean arterial blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N16
Registration date: 2020-12-15, 1399/09/25
Registration timing: prospective

Last update: 2020-12-15, 1399/09/25
Update count: 0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery under topical anesthesia and sedation
Public title
The effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
An age group of 40 to 80 years old Candidates for cataract surgery using phaco-emulsification Under topical anesthesia and sedation Classified as ASA I and ASA II based on the American Society of Anesthesiologists classification
Exclusion criteria:
History of opioids abuse Allergy to lidocaine or tetracaine History of alcohol and psychedelic abuse History of untreated systemic disease and hemodynamic disorder History of convulsion Pregnancy and breastfeeding History of mental illness Taking painkillers 24 hours before surgery Body Mass Index (BMI) > 35
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 62 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, due to the different nature of lidocaine injection in the intervention group (in the eye chamber), the researcher is aware of the treatment used for the two groups. However, the patient due to lack of consciousness and the person evaluating the patient's hemodynamic parameters and the data analyst, will not have any information about the two groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-10-31, 1399/08/10
Ethics committee reference number
IR.MUI.MED.REC.1399.664

Health conditions studied

1

Description of health condition studied
Cataract extraction
ICD-10 code
Z98.49
ICD-10 code description
Cataract extraction status, unspecified eye

Primary outcomes

1

Description
Mean arterial blood pressure
Timepoint
Immediately before the start of relaxation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery
Method of measurement
Monitoring device

2

Description
Heart rate
Timepoint
Immediately before the start of sedation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery
Method of measurement
Monitoring device

3

Description
Respiratory rate
Timepoint
Immediately before the start of sedation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery
Method of measurement
Monitoring device

4

Description
Pain score
Timepoint
Immediately upon entry to recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours and 24 hours after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: For patients in this group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. And immediately after corneal incision and before capsulorhexis, four drops of sterile BSS solution are injected into the anterior chamber.
Category
Treatment - Surgery

2

Description
Intervention group: Intervention group: For patients in the intervention group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. Immediately after corneal incision and before capsulorhexis, four drops of 1% lidocaine are injected into the anterior chamber without preservatives.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Daroush Moradi Farsani
Street address
Ayatollah Modarres Street, Quds Square
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
dmoradi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Daroush Moradi Farsani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
dmoradi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Daroush Moradi Farsani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
dmoradi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vahid Mohammadi
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hopital, Ayatollah Modarres Street, Ghods Square, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
vahidmohammadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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