]>
IRCT20180625040232N9 IRCT 2022-05-27 Oroumia University of Medical Sciences Assessment of Gabapentin effect in patients undergoing laparoscopic urology surgery Assessment of Gabapentin effect on postoperative pain, nausea, and vomiting in patients undergoing laparoscopic urology surgery 2022-06-21 anticipated 42 Complete https://irct.ir/trial/63674 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. Patients will be allocated to groups based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. Placebo capsules will be similar in shape and size to gabapentin capsules. Gabapentin and placebo capsules will be coded A and B. 3 laparoscopic urology. Intervention 1: Intervention group: Patients in the intervention group will receive a number 300 mg capsule of gabapentin 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery (each patient will receive a total of three capsules). Intervention 2: Control group: Patients in the placebo group will receive a number 300 mg capsule of placebo 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Saman Farshid
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 farshid.s@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Saman Farshid
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 farshid.s@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients candidate for laparoscopic urology Age between 18 and 65 years Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II) 18 years 65 years Both Having any coagulopathy Opium addiction PK80.6 Urological procedure associated with injury or harm in therapeutic use Treatment - Other N/A Intervention group: Patients in the intervention group will receive a number 300 mg capsule of gabapentin 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery (each patient will receive a total of three capsules). Control group: Patients in the placebo group will receive a number 300 mg capsule of placebo 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery. Pain. Timepoint: 6, 24, 12 and 48 hours after surgery. Method of measurement: Visual analogue scale (VAS). Nausea and vomiting. Timepoint: 6, 24, 12 and 48 hours after surgery. Method of measurement: Post operative nausea and vomiting scale (PONV scale). Dosage of analgesic. Timepoint: Up to 48 hours after surgery. Method of measurement: milligram. Receiving anti-nausea and vomiting medicine. Timepoint: Up to 48 hours after surgery. Method of measurement: yes/ no. Oroumia University of Medical Sciences Approved 2022-03-13 Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)