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

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

The present study is a clinical trial, with parallel groups, randomized (using block randomization), phase 3 on 140 patients.

In this double-blind randomized clinical trial, patients who are candidates for inguinal hernia surgery referred to Waliasr Hospital in Arak will be divided into two identical groups: dexmedetomidine + ropivacaine and ketamine + ropivacaine. In this study, the patients (by the label on the syringe) and the outcome assessor (by coding the patients) will be blinded. In each group, drug treatment will be prescribed subcutaneously before surgery. Finally, two groups will be evaluated in terms of study results.

Inclusion criteria: Candidate patients for inguinal hernia surgery aged 18 to 65 years; body mass index below 30; Consent to participate in the study. Exclusion criteria: history of allergy to the study drugs; smoking; Underlying disease.

Intervention group 1: Dexmedetomidine 1 microg/kg along with ropivacaine 0.75% (3 mg/kg) diluted until reaching the final volume of 10 cc of distilled water are received subcutaneously. Intervention group 2: 100 mg of ketamine with ropivacaine 0.75% (3 mg/kg) diluted until reaching the final volume of 10 cc of water are received subcutaneously.

Blood pressure, heart rate, complications of dizziness and headache, pain score, amount of narcotic drug used, duration of pain relief

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.

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.

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.

Access will be from 2024/11/20 to 2027/11/20 for 3 years.

University researchers

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.

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

Letter writing should be done with professors and universities.