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IRCT20181023041425N3 IRCT 2021-12-06 Mashhad University of Medical Sciences The comparison of Rupivacain versus Lidocain effect on intraoperative bleeding and pain, and postoperative pain after wisdom tooth surgery The comparison of Rupivacain versus Lidocain effect on intraoperative bleeding and pain, and postoperative pain after wisdom tooth surgery 2021-12-31 anticipated 60 Complete https://irct.ir/trial/60367 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization steps are as followed: for the first patient, two envelopes with the same appearance are selected, inside one of them there is a card on which dexmedetomidine in ropivacaine, and inside the other is a card on which lidocaine is written. After that, the surgeries are performed alternately. (Note that if for the first patient, surgery is performed by the ropivacaine; for the opposite tooth surgery, lidocaine will be used and vice versa.), 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 in which side ( of course during signing moral Satisfaction form ,they will be notified if they receive both of these two drugs.). 3 Condition 1: Acute pain. Condition 2: intraoperative bleeding. Intervention 1: Intervention group: includes group that received 2cc Ropivacaine 0/5% (naropin) as preoperative anesthesia. Intervention 2: Control group: includes group that received 1/8cc Lidocaine 2% with epinephrine 1/80000 (Persocaine) as preoperative anesthesia. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission Comments:
public Majid Hosseini Abrishami
Mashhad School of Dentistery, Vakilabad Ave.
Mashhad Iran (Islamic Republic of) 935659916 +98 51 3882 9501 hoseiniabrishamim@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Hosseini Abrishami
Mashhad School of Dentistery, Vakilabad Ave.
Mashhad Iran (Islamic Republic of) 935659916 +98 51 3882 9501 hoseiniabrishamim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) According to the ASA physical status classification system, patient should be ASA I or ASA II (normal healthy patient or patient with mild systemic disease) Patient with informed consent. Patient's age should be between 18-30 years. Patients should have two wisdom teeth (classified in the same class by Pell & Gregory; mesioangular impaction, level B, class 1 or 2), which are similar in terms of surgical severity No general contraindications (patients with low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, arousability, tachyphylaxis and liver disorders.) No lesions and malignancies at the surgical site; No smoking. 18 years 30 years Both Patient with wisdom tooth surgery on one side Patient who needs more than one cartridge injection Occurring medical problems during surgery; Surgery lasting more than 20 minutes. G89.1 R58 Acute pain, not elsewhere classified Hemorrhage, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: includes group that received 2cc Ropivacaine 0/5% (naropin) as preoperative anesthesia Control group: includes group that received 1/8cc Lidocaine 2% with epinephrine 1/80000 (Persocaine) as preoperative anesthesia Evaluate the amount of pain after surgery. Timepoint: 2 hour, 6 hours, 12hours, 18 hours, and 24 hours postoperatively. Method of measurement: Visual analogue scale (VAS) for pain. The amount of surgical bleeding. Timepoint: at the end of surgery. Method of measurement: Blood in suction and gauze. Evaluate the amount of pain during surgery. Timepoint: After flap removal, after osteotomy, and after tooth extraction. Method of measurement: Visual analogue scale (VAS) for pain. Mashhad University of Medical Sciences Approved 2019-12-25 Ethics Committee of Mashhad University of Medical Sciences Mashhad University of Medical Science, Daneshgah Ave, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)