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IRCT20211216053424N1 IRCT 2022-05-14 Oroumia University of Medical Sciences Evaluation of post operative pain and stress after cataract surgery after gabapentin pretreatment: a single-blind clinical trial Evaluation of post operative pain and stress after cataract surgery after gabapentin pretreatment: a single-blind clinical trial 2022-06-22 anticipated 44 Complete https://irct.ir/trial/61101 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Cataract Surgery. Intervention 1: Intervention group: Gabapentin 600 mg in the form of two 300 mg capsules will be taken orally 100 minutes before topical anesthesia. Intervention 2: Control group: Two capsules very similar to gabapentin capsules containing the same amount of placebo will be taken orally 100 minutes before topical anesthesia. Yes - There is a plan to make this available What will be shared: 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: Access to information is possible one year after the publication of the results To whom: The information will be available to the academic researcher Conditions: 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. Where to obtain: co-responding author How to obtain: By official or academic email Comments:
public Reza Soudi
Imam Khomeini University Hospital-Ershad Ave-Modarres Blvd-Urmia-Iran
Urmia Iran (Islamic Republic of) 57157-81351 0098334595383 rezasoudi@gmail.com Oroumia University of Medical Sciences scientific Reza Soudi
Imam Khomeini University Hospital-Ershad Ave-Modarres Blvd-Urmia-Iran
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 9538 rezasoudi@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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 Treatment - Drugs Placebo Intervention group: Gabapentin 600 mg in the form of two 300 mg capsules will be taken orally 100 minutes before topical anesthesia. Control group: Two capsules very similar to gabapentin capsules containing the same amount of placebo will be taken orally 100 minutes before topical anesthesia. 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. 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). Oroumia University of Medical Sciences Approved 2021-11-10 Ethics committee of Urmia University of Medical Sciences UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran Urmia West Azarbaijan Iran (Islamic Republic of)