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IRCT201212168729N5 IRCT 2014-09-07 Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences Comparison of the effects of Ofsar and Lidocaine - Prilocaine ointments on pain after surgery A comparative study of the analgesic effects of Ofsar and Lidocaine - Prilocaine ointments in relief of pain after inguinal hernia surgery 2014-09-23 anticipated 50 Complete https://irct.ir/trial/9222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Based on gradual entering of samples the following method will be used for random selection and blinding of the study: Fifty dark packets numbered from 1 to 50 are given to the evaluating physician. A card is placed inside the packets with the label A or B. the A and B written on the packets will be designated using randomized numbers table. When the first patient refers, packet number 1 is opened by the evaluating physician and patient is allocated to the group designated within the packet. Neither the physician, nor the patient, nor the analyst are aware of the contents of the drugs and only our representative is aware. It should be noted that one of our colleagues is present in all the stages of extract, ointment production and coding. This colleague played no role in sampling and drug delivery to patients. 3 Inguinal hernia. Intervention 1: Intervention group1: Number of examinees: 25 After inguinal hernia repair, Ofsar ointment is applied to the incision margin every 8 hours for 48 hours and analgesic effect will be determined by NRS. Intervention 2: Intervention group2: Number of examinees: 25 After inguinal hernia repair, Lidocaine-Prilocaine ointment is applied to the incision margin every 8 hours for 48 hours and analgesic effect will be determined by NRS.
public Saeed Bashirian
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences, Shaeed fahmideh Blvd., Hamadan, Iran
Hamadan Iran (Islamic Republic of) +98 81 3838 0717 Vc_research@umsha.ac.ir Hamadan University of Medical Sciences scientific Seyyed Mohammadreza Javadi
Besat Hospital, Resalat Sq., Shaheed Motahhari Blvd., Hamadan
Hamadan Iran (Islamic Republic of) +98 81 1264 0021 mr.javadi@umasha.ac.ir Hamadan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Patients with unilateral inguinal hernia who refer to Besat hospital 2. Incision size less than 20cm 3. General Anesthesia with endotracheal tube 4. Age more than 18 Exclusion criteria: 1. Patient under treatment of analgesics 2. Hypersensitivity to amides anesthetics 3. Patient who undergo nerve block except for epidural nerve block 4. Incarcerated and strangulated hernia 18 years 75 years Male K40.9 Unilateral or unspecified inguinal hernia, without obstruction or gangrene Treatment - Drugs Treatment - Drugs Intervention group1: Number of examinees: 25 After inguinal hernia repair, Ofsar ointment is applied to the incision margin every 8 hours for 48 hours and analgesic effect will be determined by NRS. Intervention group2: Number of examinees: 25 After inguinal hernia repair, Lidocaine-Prilocaine ointment is applied to the incision margin every 8 hours for 48 hours and analgesic effect will be determined by NRS. Pain. Timepoint: Every 8 hours during 48 hours after surgery. Method of measurement: Numerical Rating Scale. The total amount of pethidine consumed. Timepoint: During 48 hours after surgery. Method of measurement: Milligram (mg). Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences Approved 2013-04-30 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shaheed Fahmide Blvd., Hamadan, Iran Hamadan Iran (Islamic Republic of)