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IRCT20170718035163N1 IRCT 2019-07-20 Mashhad University of Medical Sciences Evaluation of using Ropivacaine in orthognathic surgery Evaluation of using Ropivacaine as a long acting anesthesia on systemic factors, amount of using opioid and bleeding during operation and post-operative pain in orthognathic surgery comparing with lidocaine 2019-05-22 anticipated 40 Complete https://irct.ir/trial/38811 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method of this study is blocked.This method is used to prevent significant imbalances in the number of participants assigned to each group. This randomization guarantees that during periods of randomization, no significant imbalance exists between groups For this method, the size of each block must first be determined and Then write the list of blocks and assign them numbers.The randomization unit is individual.The randomization tool is Statistical software , Blinding description: In this study blinded groups involves patients and persons who analyses the data. Participants will be unaware of the fact that they receive Rupvacaine or Lidocaine ( of course during signing moral Satisfaction form ,they will be notified if they receive one of these two drugs.) Data will be grouped into groups A and B for delivery to the statistician. The statistician is unaware of which group of drugs he received. 3 Cl III jaw deformity. Intervention 1: Intervention group: includes group that 2cc Ropivacaine 0/5% (naropin) as preoperative anesthesia at BSSO incision and 4cc at lefort incision before begining orthognathic surgery are used. Intervention 2: Control group: includes group that 1/8cc Lidocaine 2% with epinephrine 1/80000 (Persocaine) as preoperative anesthesia at BSSO incision and 3/6cc at lefort incision before begining orthognathic surgery are used. 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 not more information.
public Mozhgan Kazemian
Dentistry faculty, Azadi square, Vakil abad Blvd
Mashhad Iran (Islamic Republic of) 91735 +98 51 3882 9501 kazemianmz@mums.ac.ir Mashhad University of Medical Sciences scientific Mozhgan Kazemian
Dentistry faculty, Azadi square, Vakil abad Blvd
Mashhad Iran (Islamic Republic of) 91735 +98 51 3882 9501 kazemianmz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patients who have cl III with discrepancy up to 10 mm. 18 years no limit Both The patients who have systemic diseases especially kidney disease. The patients who have history of allergy to drugs using in the study K07.1 Anomalies of jaw-cranial base relationship Treatment - Surgery Treatment - Surgery Intervention group: includes group that 2cc Ropivacaine 0/5% (naropin) as preoperative anesthesia at BSSO incision and 4cc at lefort incision before begining orthognathic surgery are used. Control group: includes group that 1/8cc Lidocaine 2% with epinephrine 1/80000 (Persocaine) as preoperative anesthesia at BSSO incision and 3/6cc at lefort incision before begining orthognathic surgery are used. Systemic factors including heart rate, mean arterial pressure, breathing, SPo2. Timepoint: Evaluating systemic factors 15, 30, 45, 60, 75, 90, 105, 120 minutes after starting the surgery. Method of measurement: Monitoring device. Evaluating the amounts of pain after surgery. Timepoint: Evaluating pain 2, 6, 12, 18, 24 hours after surgery. Method of measurement: VAS scale. Amounts of using narcotics during surgery. Timepoint: Measuring narcotic consumption after starting surgery. Method of measurement: Determined by anesthetic team. Mashhad University of Medical Sciences Approved 2019-04-28 Ethics committe of mashhad university of medical Sciences Qoreyshi building,facing 18th Daneshgah,Daneshgah street,Mashhad,Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)