Evaluation of the effect of intracameral marcaine and lidocaine on postoperative pain after cataract surgery in patients undergoing intravenous sedation
Design
Two arm parallel group randomized clinical trial, double blinded, randomized
Settings and conduct
64 cataract patients will be included in the study and will be randomly divided into two groups. In the first group, local anesthesia and sedation and intracameral lidocaine are used. But in the second group, in addition to local anesthesia and intravenous sedation, marcaine will be injected into the anterior chamber of the eye. Then the pain and hemodynamic parameters of the patients are evaluated.
Participants/Inclusion and exclusion criteria
All adult patients with cataracts, regardless of etiology, in the age range of 20-70 years with the class of American Anesthesia Association 1 and 2 who have informed consent enter the study. Exclusion criteria are drug addiction; taking sedatives in last 24 hours; anxiety and other documented psychologic disease and BMI more than 35.
Intervention groups
For patients in both groups, to induce local anesthesia, a drop of 0.5% ocular tetracaine is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of the surgery. In the first intervention group, we inject 0.2 cc of lidocaine 1% without preservative into the anterior chamber immediately after corneal incision and before capsulorexia. In the second intervention group, after receiving topical tetracaine drops as in group 1, immediately after corneal incision and before capsulorexia 0.2 cc of half a percent marcaine without preservative diluted in a 1: 1 ratio with sterile BSS solution into the anterior chamber.
Main outcome variables
Pain; mean arterial pressure; oxygen saturation; patient satisfaction; duration of surgery; average recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210902052364N1
Registration date:2021-09-15, 1400/06/24
Registration timing:prospective
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
Samira Yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5743 4093
Email address
samira.yavari1368@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of intracameral marcaine and lidocaine on postoperative pain after cataract surgery in patients undergoing intravenous sedation
Public title
The effect of intracameral marcaine and lidocaine on postoperative pain after cataract surgery in patients undergoing intravenous sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients with cataracts, regardless of etiology
Age range of 20-70 years old
Class of American Anesthesia Association 1 and 2
Informed consent to enter the study
Exclusion criteria:
Drug addiction
Taking sedatives in last 24 hours
Anxiety and documented psychologic disease
BMI more than 35
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 64 eligible patients will be selected by simple random sampling. These people are then coded with the help of random allocation computer software and are 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 studied in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, due to the different nature of the injection (intracameral), the researcher is aware of the two types. However, due to lack of consciousness and the person evaluating the patient's hemodynamic parameters and analyzing the data, the patient will not be aware of the two groups.
Placebo
Not 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
Isfahan University of Medical sciences, Hezar jarib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUI.MED.REC.1400.355
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
Postoperative pain
Timepoint
Before anesthesia induction, 15 and 30 minutes after surgery, immediate after entering to the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Visual analogue scale
2
Description
Mean arterial pressure
Timepoint
Before anesthesia induction, 15 and 30 minutes after surgery, immediate after entering to the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Mercury pressure gauge
3
Description
Heart rate
Timepoint
Before anesthesia induction, 15 and 30 minutes after surgery, immediate after entering to the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Heart monitoring
4
Description
Oxygen saturation
Timepoint
Before anesthesia induction, 15 and 30 minutes after surgery, immediate after entering to the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Pulse oxymetr
5
Description
Patient satisfaction
Timepoint
At the end of recovery time
Method of measurement
Questionnaire
6
Description
Surgery duration
Timepoint
At the end of surgery
Method of measurement
Patient document
7
Description
Recovery time duration
Timepoint
At the end of recovery
Method of measurement
Patient document
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: we inject 0.2 cc of lidocaine 1% without preservative into the anterior chamber immediately after corneal incision and before capsulorexia.
Category
Treatment - Drugs
2
Description
Intervention group: In the second intervention group, after receiving topical tetracaine drops as in group 1, immediately after corneal incision and before capsulorexia 0.2 cc of half a percent marcaine without preservative diluted in a 1: 1 ratio with sterile BSS solution into the anterior chamber.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Dr Dariush Moradi Farsani
Street address
Feiz hospital, Ghods square,
City
Isfahan
Province
Isfehan
Postal code
4487481496
Phone
+98 31 3445 2034
Email
Feiz@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Street address
Isfahan, hezar jarib street, medical university
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?