Evaluation of post operative pain and stress after cataract surgery after gabapentin pretreatment
Design
In this single-blind clinical trial, 44 patients who underwent cataract surgery will be included. The control and intervention groups will consist of 22 patients each, who will be categorized by simple randomization and drawing.
Settings and conduct
The study will be carried out in the ophthalmology ward of Imam Khomeini Hospital in Urmia. One hundred minutes before topical anesthesia, patients in the intervention group will be given two 300 mg gabapentin capsules and patients in the control group will be given two similar capsules containing placebo for oral administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age between 18 to 75 years 2- Class 1 and 2 patients based on American society of Anesthesiologist (ASA) Classification (Class 1 includes individuals without underlying disease and Class 2 includes individuals with mild underlying disease) 3- Cataract surgery 4- consent to participate in the study
Exclusion criteria: 1- Emergency surgery 2- Gabapentin allergy 3- BMI above 35 4- psychology disorders 5- Autoimmune disorders 6- using Warfarin 7- opium or alcohol abuse 8- Diabetes Mellitus 9- History of malignancy and Tumor resection.
Intervention groups
The intervention group received 600 mg of gabapentin 100 minutes before topical anesthesia and the placebo group received the same capsule containing placebo at the same time.
Main outcome variables
Post operative pain and stress severity after cataract surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211216053424N1
Registration date:2022-05-14, 1401/02/24
Registration timing:prospective
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Parvin Khaleghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4234 0827
Email address
pkhaleghi1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of post operative pain and stress after cataract surgery after gabapentin pretreatment: a single-blind clinical trial
Public title
Evaluation of post operative pain and stress after cataract surgery after gabapentin pretreatment: a single-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 75 years
Class 1 and 2 patients based on American society of Anesthesiologist (ASA) Classification (Class 1 includes individuals without underlying disease and Class 2 includes individuals with mild underlying disease)
Cataract surgery
consent to participate in the study
Exclusion criteria:
Emergency surgeries
Allergic reaction to Gabapentin
BMI more than 35 kg/m2
Psychologic disorders
Autoimmune disorders
Diabetes mellitus
Warfarin use
Opium or alcohol addiction
History of Malignancy and tumor resection surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, drawing will be performed for simple randomization. Before starting the study, drawing will be performed for numbers among 1 to 44 and the first 22 drew numbers will consider as intervention group and other numbers will consider as control group. Then, after starting the study, numbers 1 to 44 will been dedicated to patients in order of their admission time.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blinding, by cooperating with a Gabapentin producer company, 88 capsules which are exactly similar, including 44 capsules contains 300 mg Gabapentin and 44 capsules contains same amount of placebo will be bought. Then 100 minutes before topical anesthesia, by considering the intervention or control group, nurse or researcher will give two placebo or Gabapentin capsules for oral consuming to each patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.UMSU.REC.1400.307
Health conditions studied
1
Description of health condition studied
Cataract Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of gabapentin pretreatment on pain severity based on Visual analogue Scale
Timepoint
15 minutes before surgery, when discharge from recovery, 12 hours and 24 hours after surgery
Method of measurement
Visual analogue Scale
Secondary outcomes
1
Description
Evaluation of the effect of gabapentin pretreatment on stress level based on GAD-7 after's cataract surgery
Timepoint
15 minutes before surgery, at the time of discharge from recovery, 12 hours and 24 hours after surgery
Method of measurement
General Anxiety Disorder Assessment (GAD-7)
Intervention groups
1
Description
Intervention group: Gabapentin 600 mg in the form of two 300 mg capsules will be taken orally 100 minutes before topical anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Two capsules very similar to gabapentin capsules containing the same amount of placebo will be taken orally 100 minutes before topical anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmology ward of Urmia Imam Khomeini university Hospital
Full name of responsible person
Reza Soudi
Street address
Imam Khomeini university Hospital, Ershad Ave, Modarres Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3345 9538
Fax
+98 44 3346 9935
Email
pkhaleghi1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
pkhaleghi1995@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistance professer
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad Ave-Modarres Blvd-Urmia-Iran
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
0098334595383
Email
rezasoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad Ave-Modarres Blvd-Urmia-Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
rezasoudi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad Ave-Modarres Blvd-Urmia-Iran
City
urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
rezasoudi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The demographic data can be accessible after the publication of the results also by consideration of maintaining the ethical principles and in accordance with the rules.
When the data will become available and for how long
Access to information is possible one year after the publication of the results
To whom data/document is available
The information will be available to the academic researcher
Under which criteria data/document could be used
The academic researcher can access the results by electronic E-mailing with the co-responder author of the study. Their request should be clear and in line with legal and ethical standards and only for further studies or statistical analysis.
From where data/document is obtainable
co-responding author
What processes are involved for a request to access data/document