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IRCT20220613055157N1 IRCT 2022-06-19 Tehran University of Medical Sciences The effect of melatonin on postoperative pain Evaluation of preoperative administration of the oral melatonin on postoperative pain in lumbar spinal surgeries 2022-02-20 anticipated 60 Complete https://irct.ir/trial/64213 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use block randomization method, a subtype of the restricted randomization. Blocking is usually used for balance in the number of samples assigned to each study group. This feature helps researchers to have equal numbers of samples assigned to each of the case groups when the intermediate analyzes are required during the sampling process. The size of all the blocks is equal and in this RCT we used two-group trial of 6 blocks (including 3 participants in the intervention group and 3 participants in the placebo group). Random allocation software are used as randomization tools. Random sequence generation software in addition to simple randomization capable generates random sequences by block generation method. For hiding, we used allocation concealment. A method for random sequencing of the study participants in a way that before the individual is assigned, the assigned group is not specified. By using sequentially numbered, sealed, opaque envelopes in which the created random sequences are registered on a card. The cards are placed in the envelopes in order. To maintain a random sequence, also on the outer surface of the envelope. The numbering is done in the same way. Finally the envelope are pasted and placed in a box, respectively. At time to start registration of participants, based on the order of entry of the eligible applicants. One of the envelopes is opened in order and the assigned group of the participant will be revealed, Blinding description: In this study, participants (patients) as well as the researcher and outcome assessor(one person has the both latter roles) are blind. The patient is unaware that he is taking the drug or placebo exactly. The lead researcher, who also evaluats the outcome of the study, similarly do not know which patient receives either the medication or the placebo. 3 lumbar spine surgery. Intervention 1: Intervention group: 5 mg of oral melatonin one hour before surgery. Intervention 2: Control group: Control group: placebo one hour before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mohammad reza Sedighi
No. 16, Goodarzi St., Heidari St., Moghaddas Ardebili Blvd., Zaferanieh
Tehran Iran (Islamic Republic of) 1986934831 +98 21 3645 6191 m.sedighi96@gmail.com Tehran University of Medical Sciences scientific Mohammad reza Sedighi
No. 16, Goodarzi St., Heidari St., Moghaddas Ardebili Blvd., Zaferanieh
Tehran Iran (Islamic Republic of) 1986934831 +98 21 3645 6191 m.sedighi96@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Satisfaction for participation in the study candidates for lumbar spinal surgeries no limit no limit Both Lack of cooperation in the study Opioid abuse Use of any other sedatives Taking drugs that interfere with melatonin non-elective surgery coagulative disorders kidney or liver failure history of drug allergy to melatonin Treatment - Drugs Placebo Intervention group: 5 mg of oral melatonin one hour before surgery Control group: Control group: placebo one hour before surgery Severity of post operative pain based on Visual Analogue Scale(VAS). Timepoint: Measurement of pain severity at 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale(VAS). Tehran University of Medical Sciences Approved 2021-10-06 Ethics committee of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)