Protocol summary

Summary
This study is a double-blind clinical trial because patients were anesthetized, and they were not aware of intraocular injection and evaluation was performed by an anesthesiologist who did not know the code of patients. The purpose of this study is to reduce postoperative pain after cataract surgery. Study patients consisted 48 male and female candidates for cataract surgery and cases with liver and kidney failure, hypothyroidism, hyperthyroidism, uncontrolled diabetes, or uncontrolled hypertension were excluded from the study. They were randomized completely into two groups (each one 24 cases) and both groups by the same drugs were placed under general anesthesia: midazolam 0.2 mg/kg, fentanyl 2 µg/kg, thiopental sodium 4 mg/kg, atracurium 0.05 mg/kg. In the study group after induction and washing and cutting the cornea to the anterior chamber, 0.1 mg of lidocaine 1% was injected and in the control group, lidocaine was not injected. Pain of the patients was evaluated based on the pain scale ranging from 0 to 10 just after their admission to recovery, and 1, 2, and 3 hours after their transition to the recovery. Moreover, their blood pressure, heart rate and complications such as itching was evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072518589N1
Registration date: 2015-03-16, 1393/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Fatemeh Zamani
Name of organization / entity
Ahvaz Jondishapour University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 1994
Email address
zamani.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing the effects of lidocaine injection and non-injection into the anterior chamber of the eye on pain reduction after cataract surgery with general anesthesia
Public title
Effect of lidocaine injection on postoperative pain of cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men and women with an age range of 20 to 80 years to undergo cataract surgery with general anesthesia. Exclusion criteria: liver and kidney failure, hypothyroidism, hyperthyroidism, uncontrolled diabetes, uncontrolled hypertension.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The table of random numbers used for randomization. Each patient is assigned a code by who does not know about the protocol of the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
61946-46343
Approval date
2014-05-10, 1393/02/20
Ethics committee reference number
45. 1393. ajums. REC

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H25 ,H26
ICD-10 code description
Senile cataract and other cataract

Primary outcomes

1

Description
Pain
Timepoint
Admission to recovery, 1, 2, 3 hours after the transition to the recovery
Method of measurement
Questionnaire vas of 0 to 10

Secondary outcomes

empty

Intervention groups

1

Description
Group 1: Single injection of 0.1 mg of lidocaine 1% of Tehran pharmaceutical drug companies into the anterior chamber after being anesthetized patient. Group 2: no injection of lidocain.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ahmadreza mohtadi
Street address
Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Fatemeh Zamani
Position
Resident Of Anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jondishapour University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
61946-46343
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
fatemeh_za58@yahoo.c0m
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Ahmadreza Mohtadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
College of Medicine, Ahvaz Jondishapour University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
61946-46343
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
Mohtadi:-ar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Fatemeh Zamani
Position
Resident Of Anesthesiology
Other areas of specialty/work
Street address
Pain Research Center, Fourth Floor of Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Postal code
61946-46343
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
zamani.f@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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