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IRCT20220727055567N1 IRCT 2022-08-12 Tabriz University of Medical Sciences The effect of fentanyl in reducing pain after jaw surgery Comparing effects of local injection of bupivacaine with and without fentanyl at the site of surgery in open reduction mandibular surgeries on acute pain intensity and opioid requirement: a randomized clinical trial 2022-08-03 anticipated 44 Complete https://irct.ir/trial/65112 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sampling will be done among the patients referred to the maxillofacial surgery department of Imam Reza Hospital in Tabriz who is eligible for the study. The randomization method is simple and its unit is the individual. Our tool for randomizing is the random number table. Accordingly, the type of treatment is marked with the code A (bupivacaine with fentanyl) and B (bupivacaine without fentanyl) and will be placed inside the sealed envelopes; Then the envelopes will be placed in a bag and mixed. After that, it will be randomly chosen from the bag and upon viewing the code, the treatment will be given to the patient. None of the patients will be informed about the treatment of another patient, Blinding description: This study is double-blind, so patients do not know which group they will be in. The researcher who must enter data into the checklist will not know which intervention was conducted. Patients are aware of the existence of two types of treatment, but they do not know which group they belong to. 2 Fracture of mandible. Intervention 1: Intervention group: After the surgery is completed and the sutures are applied, 2 cc of Bupivacaine solution (Exir Company-Iran) 0.5% (5 mg/ml) along with 25 micrograms of fentanyl routinely used in the hospital will be injected into the surgical site through an insulin syringe. After discharge from recovery, patients' pain will be measured by a ten-point VAS scale for 24 hours every four hours. Also, the amount of opioid medication needed based on milligrams of pethidine will also be recorded for patients. If the pain intensity of the patients is higher than 5, pethidine will be injected intramuscularly at the rate of 1 mg/kg. Intervention 2: Control group: After the surgery is completed and the sutures are applied, 2 cc of Bupivacaine solution (Exir Company-Iran) 0.5% (5 mg/ml) will be injected into the surgical site by an insulin syringe. After discharge from recovery, patients' pain will be measured by a ten-point VAS scale for 24 hours every four hours. Also, the amount of opioid medication needed based on milligrams of pethidine will also be recorded for patients. If the pain intensity of the patients is higher than 5, pethidine will be injected intramuscularly at the rate of 1 mg/kg. 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 Saeed Nezafati
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 nezaf2000@yahoo.com Tabriz University of Medical Sciences scientific Saeed Nezafati
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 nezaf2000@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Candidate patients for open mandibular surgery Age above 18 years Duration of surgery less than 4 hours Candidate patients for general anesthesia Consent to jaw fixation 18 years no limit Both Unwillingness to cooperate in the study The occurrence of any complications that prevent participation in the study Hypersensitivity to fentanyl, bupivacaine, and other drugs The patient's lack of satisfaction with intermaxillary fixation after the operation Existence of underlying disease and confounding factor such as: hemorrhagic diseases and coagulopathy, kidney and liver diseases, mental and neurological diseases, obstructive lung diseases, hemostatic disorders and dialysis in patients Addiction to drugs and psychoactive substances and history of drug abuse The presence of infection in the operation site History of taking antidepressants and sedatives and any medicine that changes the perception of pain S02.6 Fracture of mandible Treatment - Drugs Treatment - Drugs Intervention group: After the surgery is completed and the sutures are applied, 2 cc of Bupivacaine solution (Exir Company-Iran) 0.5% (5 mg/ml) along with 25 micrograms of fentanyl routinely used in the hospital will be injected into the surgical site through an insulin syringe. After discharge from recovery, patients' pain will be measured by a ten-point VAS scale for 24 hours every four hours. Also, the amount of opioid medication needed based on milligrams of pethidine will also be recorded for patients. If the pain intensity of the patients is higher than 5, pethidine will be injected intramuscularly at the rate of 1 mg/kg. Control group: After the surgery is completed and the sutures are applied, 2 cc of Bupivacaine solution (Exir Company-Iran) 0.5% (5 mg/ml) will be injected into the surgical site by an insulin syringe. After discharge from recovery, patients' pain will be measured by a ten-point VAS scale for 24 hours every four hours. Also, the amount of opioid medication needed based on milligrams of pethidine will also be recorded for patients. If the pain intensity of the patients is higher than 5, pethidine will be injected intramuscularly at the rate of 1 mg/kg. The amount of pain. Timepoint: Every four hours for 24 hours after surgery. Method of measurement: Visual Analogue Scale. The amount of opioid use. Timepoint: Every four hours for 24 hours after surgery. Method of measurement: After surgery, the pain level is measured every four hours for 24 hours. If VAS is higher than 5, Pethidine (Exir Company-Iran) will be injected intramuscularly at the rate of 1 mg/kg. After four hours, if the pain repeats, Pethidine injection at the rate of 1 mg/kg will be repeated. The number of times the patient needs pethidine in twenty-four hours will be recorded. Tabriz University of Medical Sciences Approved 2022-06-27 كميته اخلاق دانشگاه علوم پزشکی تبریز Golgasht St., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)