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IRCT20170805035510N8 IRCT 2022-01-22 Tehran University of Medical Sciences Evaluation of the effect of scalp block in controlling pain and opioid use during and after surgery under Analgesia Nociception Index (ANI) monitoring in patients with elective craniotomy Evaluation of the effect of scalp block in controlling pain and opioid use during and after surgery under Analgesia Nociception Index (ANI) monitoring in patients with elective craniotomy 2022-04-05 anticipated 72 Complete https://irct.ir/trial/60874 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the website www.sealedenveipoe.com, quadruple blocks were generated for randomization. The number of generated blocks will be 20 (sample size 72). The website generates blocks randomly (taking into account the number of study groups In each block are equal to each other) then they are provided to the person as Excel output. The determination of entry to the study is done based on the blocks made in order. Do not know or control groups based on generated blocks. 3 craniotomy. Intervention 1: Intervention group: One-sided scalp block will be performed under sterile conditions with bupivacaine 2mg / kg and diluted epinephrine 1: 200000. Pain intensity, prescribed opioid dose as well as hemodynamic parameters during induction (T0), during operation (T6) and painful stimulation times such as intubation (T1), fixation of head pins (T2), skin incision (T3), craniotomy (T4), opening Dora (T5) and closing the skin (T7) and while waking the patient (T8) will be recorded at these times. Intervention 2: Control group: Control group: Craniotomy patients undergoing general anesthesia undergo surgery according to the protocol of the intervention group without scalp block and the amount of drug use and pain are compared with the intervention group. 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 Pejman Pourfakhr
Tehran University of Medical Sciences, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 4466 3963 pourfakhr@tums.ac.ir Tehran University of Medical Sciences scientific Pejman Pourfakhr
Tehran University of Medical Sciences, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 4466 3963 pourfakhr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) ASA class 1,2 Elective Craniotomy 18 years 70 years Both previous craniotomy pregnancy Patients with arrhythmia Patients taking beta blockers Chronic drug use Treatment - Drugs Treatment - Drugs Intervention group: One-sided scalp block will be performed under sterile conditions with bupivacaine 2mg / kg and diluted epinephrine 1: 200000. Pain intensity, prescribed opioid dose as well as hemodynamic parameters during induction (T0), during operation (T6) and painful stimulation times such as intubation (T1), fixation of head pins (T2), skin incision (T3), craniotomy (T4), opening Dora (T5) and closing the skin (T7) and while waking the patient (T8) will be recorded at these times. Control group: Control group: Craniotomy patients undergoing general anesthesia undergo surgery according to the protocol of the intervention group without scalp block and the amount of drug use and pain are compared with the intervention group. The effect of scalp block in controlling pain and drug intake during and after surgery. Timepoint: Every 20 min. Method of measurement: ANI (MetroDoloris). Tehran University of Medical Sciences Approved 2021-04-22 Ethics Committee of Tehran University of Medical Sciences and Health services Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)