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IRCT20110528006617N8 IRCT 2023-10-29 Esfahan University of Medical Sciences The Effect of Regional Scalp Block and Pin-Site Infiltration on Heart Rate and Blood Pressure Assessment of the Effect of Regional Scalp Block and Pin-Site Infiltration on Heart Rate and Blood Pressure in Skull Pinning in Posterior Cervical Fusion Surgery: randomized control trial 2023-11-06 anticipated 102 Complete https://irct.ir/trial/72391 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling in this research is done in two stages. In the first stage, samples will be entered continuously based on the criteria for entering the study. In the second stage, the samples are assigned to groups in the form of a random permutation block design of three groups with blocks of three. In this way, the letter A is for the regional Regional Scalp Block, group B is for the Pin-Site Infiltration, and the letter C is for the regional scalp block group. The control group is considered. Then, all substitution compounds will be extracted from the site below until the sample size reaches the quorum. https://www.sealedenvelope.com/simple-randomiser/v1/lists To avoid bias, this work will be done by someone other than the researcher, Blinding description: In this study, patients and people involved in data collection and analysis are not aware of the grouping. After obtaining informed consent from eligible patients, they are randomly placed in 3 groups R, P and control, and the patients do not know which group they are in. After general anesthesia, a skilled doctor injects the drug. In the first group, injection is done in 4 areas, in the second group, in two areas. In the third group, no injection is performed. The person collecting the data does not know which group the patient belongs to. The person responsible for analyzing the data does not know which group this data belongs to. 3 Posterior cervical fusion surgery. Intervention 1: First intervention group: Regional Scalp Block (RSB) In this group, with a 25-gauge needle, we inject a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) bilaterally in the 4 areas of the supra-trochlear, supra-orbital, zygomaticotemporal, and auricotemporal nerves with a 25-gauge needle. Intervention 2: Second intervention group: Pin-Site Infiltration (PSI) In this group, a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) is injected bilaterally at the pinning site with a 25 gauge needle. Intervention 3: Control group: They are only under general anesthesia. General anesthesia includes 1.5 to 2 mg/kg of propofol, 0.03 to 0.05 mcg/kg of fentanyl, and 0.5 mg/kg of atracurium. 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 further information
public Mehrdad Masoudifar
elective operating room, Al Zahra hospital, Soffeh Blvd, Isfahan, Isfahan province
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 0000 masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Masoudifar
Al Zahra hospital, Sofeh blv, Isfahan, Isfahan province
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 7898 masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate patients for posterior cervical fusion surgery Age 18 to 65 years Completing the informed consent form American Society of Anesthesiologists I, II 18 years 65 years Both Previous incision and previous history of cervical surgery Allergy to local anesthetic Drug or alcohol addiction Treatment - Drugs Treatment - Drugs Other First intervention group: Regional Scalp Block (RSB) In this group, with a 25-gauge needle, we inject a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) bilaterally in the 4 areas of the supra-trochlear, supra-orbital, zygomaticotemporal, and auricotemporal nerves with a 25-gauge needle. Second intervention group: Pin-Site Infiltration (PSI) In this group, a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) is injected bilaterally at the pinning site with a 25 gauge needle. Control group: They are only under general anesthesia. General anesthesia includes 1.5 to 2 mg/kg of propofol, 0.03 to 0.05 mcg/kg of fentanyl, and 0.5 mg/kg of atracurium. Systolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure. Diastolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure. Heart rate. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: electrocardiogram(ECG). Mean blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure. Saturation of Peripheral Oxygen (SPO2). Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: pulse oximetry. Esfahan University of Medical Sciences Approved 2023-08-14 Ethics Committee in Research Faculty of Medicine-Isfahan University of Medical Sciences Hezarjarib Street Isfahan Isfehan Iran (Islamic Republic of)