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IRCT201402289014N28 IRCT 2014-05-26 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery: a triple blinded randomized clinical trial 2014-06-22 anticipated 102 Complete https://irct.ir/trial/9467 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be assign randomly to one the three trial groups using balance block randomization with the block of six. Blinding: The patients will receive capsules with the same shape but different content (gabapentin or starch), thus, they will not aware of the intervention. In addition, the physician who will examine the patients and the analyzer who will perform the data analysis will not aware of the intervention. Therefore, the study will be run triple blinded. 2 Pain at surgical site at inguinal area. Intervention 1: 34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery. Intervention 2: 34 patients will receive one gabapentin capsule 300 mg plus one placebo capsule (containing starch) single dose 2 hours before surgery. Intervention 3: 34 patients will receive two placebo capsules (containing starch) single dose 2 hours before surgery.
public Dr Parisa Shirzad
Beasat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 1341 6392 shirzad.parisa7@gmail.com Beasat Hospital scientific Dr Seyyed Mohammad Zolhavarieh
Beasat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 1341 6392 dsmbszolhavarieh@yahoo.com Beasat Hospital Iran (Islamic Republic of) Inclusion criteria: (a) age of 18 to 65 years; (b) women with physical class ASA I-II; (c) candidate for elective gynecologic surgery. Exclusion criteria: (a) contraindication for neuroaxial anesthesia; (b) history of hypertension or diabetes mellitus; (c) using narcotics or psychotropic. 18 years 65 years Both R10.3 Pain localized to other parts of lower abdomen Treatment - Drugs Treatment - Drugs Placebo 34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery 34 patients will receive one gabapentin capsule 300 mg plus one placebo capsule (containing starch) single dose 2 hours before surgery 34 patients will receive two placebo capsules (containing starch) single dose 2 hours before surgery Pain at the surgical site. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: using VAS scale. The amount of narcotic used. Timepoint: during the first 48 hours after surgery. Method of measurement: per mg. The duration of time to receive narcotic. Timepoint: during the first 48 hours after surgery. Method of measurement: per min. Vertigo. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question. Nausea and vomiting. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question. Pruritus. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2014-05-17 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)