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IRCT20191104045328N23 IRCT 2024-08-17 Arak University of Medical Sciences Investigating two medicinal combinations of Ropivacaine-Dexmedetomidine and Ropivacaine-Ketamine by subcutaneous method in postoperative pain control in Inguinal hernia candidate patients Comparison of the effect of two medicinal combinations Ropivacaine-Dexmedetomidine and Ropivacaine-Ketamine by subcutaneous method in controlling postoperative pain in patients with Inguinal hernia candidates 2024-06-18 anticipated 140 Complete https://irct.ir/trial/77237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced, Blinding description: Medicines will be in pre-drawn and labeled syringes. Therefore, the participants will not know the type of drug injected. In addition to this, the outcome evaluator (surgical assistant) does not know the type of drugs and follows up the results based on the patient's file number and will hand them over to the main supervisor. 3 Inguinal hernia. Intervention 1: Intervention group: Dexmedetomidine 1 microgram/kg (Exir Pharmaceuticals-Iran) along with ropivacaine 0.75% (3 mg/kg) (Molteni pharmaceutical company, Italy) diluted to reach the final volume of 10 cc of distilled water are received subcutaneously. Intervention 2: Intervention group: 100 mg of ketamine (Elixir pharmaceutical company - Iran) along with ropivacaine 0.75% (3 mg/kg) (Molteni pharmaceutical company, Italy) diluted to reach the final volume of 10 cc of water will be received subcutaneously. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2024/11/20 to 2027/11/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: Academic researchers and university professors can request Dr. Reza Shojaei to use the data after contacting the relevant professor via message or email. Dr. Reza Shojaei: Phone: 09123700960 Email: R.shojaei@arak.mu.ac.ir Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Reza Shojaei
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 R.shojaei@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Alireza Kamali
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3383 8319 Alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidates for inguinal hernia surgery between the ages of 18 and 65 Body mass index below 30 Consent to participate in the study 18 years 65 years Both History of allergy to studied drugs Smoking Underlying disease K40 Inguinal hernia Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine 1 microgram/kg (Exir Pharmaceuticals-Iran) along with ropivacaine 0.75% (3 mg/kg) (Molteni pharmaceutical company, Italy) diluted to reach the final volume of 10 cc of distilled water are received subcutaneously. Intervention group: 100 mg of ketamine (Elixir pharmaceutical company - Iran) along with ropivacaine 0.75% (3 mg/kg) (Molteni pharmaceutical company, Italy) diluted to reach the final volume of 10 cc of water will be received subcutaneously. Blood pressure. Timepoint: Every 5 minutes. Method of measurement: Pressure gauge device. Heart rate. Timepoint: Every5 minutes. Method of measurement: Cardiac monitoring. Complications of dizziness and headache. Timepoint: The end of the intervention. Method of measurement: Ask the patient. Pain score. Timepoint: The amount of pain during recovery at 2, 4, 6, 12, and 24 hours after the operation. Method of measurement: Visual Analogue Scale Ruler. Amount of narcotic drug used. Timepoint: 24 hours after surgery. Method of measurement: Patient file. Duration of pain relief. Timepoint: After surgery. Method of measurement: Watch. Arak University of Medical Sciences Approved 2023-12-31 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)