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IRCT20211013052759N1 IRCT 2021-10-20 Ilam University of Medical Sciences Comparison of the oral pregabalin and gabapentin effects as a premedication in pain control after orthopedic surgery on the upper limb. Comparison of the oral Pregabalin and Gabapentin effects as a premedication in pain control after orthopedic surgery on the upper limb. 2021-11-01 anticipated 120 Complete https://irct.ir/trial/59308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: At the beginning, the candidates for surgery will be determined based on the entry and exit criteria, and then Balance-block randomization with 4 permutations will be used for random allocation Blocks used include: PPGG PGPG PGGP GGPP GPGP GPPG Where the letter P (pregabalin group) and the letter G (gabapentin group) will be. RAS (Research Analysis and Statistics) software will be used to generate random blocks and a random number table will be used to select each block. Hide created sequence To hide the created sequence, boxes will be installed that will be exactly the same and random codes will be written on them, and each code will indicate a type of drug, and the drug in the box will be exactly the same. The list of codes prepared for each drug will be determined by the research team. Hide created sequence: To hide the created sequence, boxes will be installed that will be exactly the same and random codes will be written on them, and each code will indicate a type of drug, and the drug in the box will be exactly the same. The list of codes prepared for each drug will be determined by the research team and the final list will be at the discretion of the lead researcher. This method will ensure that the doctor or nurse prescribing the medicine does not know the type of medicine, Blinding description: Volunteer patients will be aware of the type of both drugs to participate in the study before receiving the drug, but will not be aware of which of the two drugs they will receive in order to blind patients. Also, the nurses who collect the data will not be aware of which of the two drugs the patient has received. 2 Comparison of the effect of gabapantin and oral pregabalin as a prodrug in controlling pain after orthopedic surgery on the upper limb in Imam Khomeini Hospital in Ilam.. .Intervention group: 120 patients with random entry conditions will be divided into two groups: pregabalin and gabapentin, so that there will be 60 people in each group. For the pregabalin group (P) one 150gg capsule will be prescribed one hour before surgery and for the gabapentin group 300mg will be administered two hours before the start of surgery. Patients will be given standard monitoring (blood pressure, heart rate, pulse oximetry, cardiography) at the beginning of the operating room. Patients with intravenous route No. 18 will be given 500 ml of Ringer's serum.Midazolam 1mg / kg is injected into the patient as a prodrug and at a dose of 2 mg / kg propofol and 0.5 mg / kg atracurium will be used to induce anesthesia. Will be used and after reviewing the vital signs and the appropriate depth of anesthesia, the surgeon will be allowed to begin surgery. After surgery, patients are transferred to recovery and patients are evaluated at three times (exit from recovery by anesthesiologist and at 6 and 12 hours after surgery by a nurse who is not aware of the type of medication received) for pain severity using a questionnaire. The VAS standard will be performed. In case of pain in case of pain with VAS score higher than 3, morphine will be injected intravenously at a dose of 0.1 mg / kg. The dose will be recorded in the relevant questionnaire and will continue to monitor pulse oximetry to diagnose loss of consciousness or respiratory depression in these patients, and we will even prescribe supplemental oxygen if necessary. Patients will then be evaluated for postoperative pain and the average dose of morphine in the two groups receiving pregabalin and gabapentin. Also, this comparison in gender and age subgroups and body mass index will be important for us and will be examined.. 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 Rana Roshanfekr
No.201, kavand dead end, javad mosqe alley, Safa st.
لرستان Iran (Islamic Republic of) 6913884343 +98 66 4260 8531 Roshanfekrrana@gmail.com Ilam University of Medical Sciences scientific Rana Roshanfekr
No.201, kavand dead end, javad mosqe alley, safa st.
Brujerd Iran (Islamic Republic of) 6913884343 +98 66 4260 8531 Roshanfekrrana@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Having elective orthopedic surgery on one of the upper limbs with general anesthesia Age range 20_55 years ASA class one and two 20 years 55 years Both Patient or guardian dissatisfaction with participation in the study, severe hemodynamic instability, neurological disease or mental disorders, patients with a history of seizures, acute and chronic kidney disease, patients with a history of pregabalin and gabapentin allergies, alcohol and drug abuse Or a history of chronic analgesia Severe hemodynamic instability Neurological disease or mental disorders Patients with a history of seizures Acute and chronic kidney disease Patient with a history of pregabalin and gabapentin allergies alcohol and drug abuse Or a history of chronic analgesia Prevention .Intervention group: 120 patients with random entry conditions will be divided into two groups: pregabalin and gabapentin, so that there will be 60 people in each group. For the pregabalin group (P) one 150gg capsule will be prescribed one hour before surgery and for the gabapentin group 300mg will be administered two hours before the start of surgery. Patients will be given standard monitoring (blood pressure, heart rate, pulse oximetry, cardiography) at the beginning of the operating room. Patients with intravenous route No. 18 will be given 500 ml of Ringer's serum.Midazolam 1mg / kg is injected into the patient as a prodrug and at a dose of 2 mg / kg propofol and 0.5 mg / kg atracurium will be used to induce anesthesia. Will be used and after reviewing the vital signs and the appropriate depth of anesthesia, the surgeon will be allowed to begin surgery. After surgery, patients are transferred to recovery and patients are evaluated at three times (exit from recovery by anesthesiologist and at 6 and 12 hours after surgery by a nurse who is not aware of the type of medication received) for pain severity using a questionnaire. The VAS standard will be performed. In case of pain in case of pain with VAS score higher than 3, morphine will be injected intravenously at a dose of 0.1 mg / kg. The dose will be recorded in the relevant questionnaire and will continue to monitor pulse oximetry to diagnose loss of consciousness or respiratory depression in these patients, and we will even prescribe supplemental oxygen if necessary. Patients will then be evaluated for postoperative pain and the average dose of morphine in the two groups receiving pregabalin and gabapentin. Also, this comparison in gender and age subgroups and body mass index will be important for us and will be examined. Pain score in vas questionnaire. Timepoint: Measurement of pain intensity after recovery and 6 and 12 hours after surgery. Method of measurement: Visual analogue scale questionnaire. Ilam University of Medical Sciences Approved 2021-10-09 Ethics Committee of Ilam University of Medical Sciences No. 201, Kavand dead end, Javad mosque alley, Safa st. Brujerd Lorestan Iran (Islamic Republic of)