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IRCT20161126031095N4 IRCT 2023-06-24 Mazandaran University of Medical Sciences Comparison of the effect of adding dexmedetomidine with dexamethasone to bupivacaine in abdominal transverse block on pain intensity after laparoscopic cholecystectomy Comparison of the effect of adding dexmedetomidine with dexamethasone to bupivacaine in abdominal transverse block on pain intensity after laparoscopic cholecystectomy 2023-06-26 anticipated 100 Complete https://irct.ir/trial/70730 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of random allocation is the method of random blocks. In this study, the randomization method will be used to generate a random sequence using the block method and the Random allocation software. First, the informed consent form is registered by the patient in writing, and then the participants will be randomly assigned to each group, Blinding description: SNOSE method will be used to hide random allocation. This method is one of the common methods in hiding random allocation. In this method, first a random sequence is created using the mentioned software, then based on the sample size of a number of envelopes with aluminum wrappers (in order to make the content of the envelopes unclear), prepare and each of the random sequences created on It is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of starting the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. اطلاعات بیشتر درباره این نوشتار مبدأ برای اطلاعات ترجمه بیشتر، نوشتار مبدأ لازم است ارسال بازخورد پانل‌های کناری. 2 Other acute postprocedural pain. Intervention 1: Control group: Patients received 17 ml of 0.25% bupivacaine + 3 ml of 0.9% saline in a total volume of 20 ml on each side. Intervention 2: Intervention group: Patients received 17 ml of 0.25% bupivacaine + dexamethasone (4 mg) diluted in 3 ml of 0.9% saline in a total volume of 20 ml on each side. Intervention 3: Intervention group: Patients received 17 ml of 0.25% bupivacaine + dexmedetomidine (1 µg/kg) diluted in 3 ml of 0.9% saline in a total volume of 20 ml on each side. 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 Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Mazandaran University of Medical Sciences scientific Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) ASA class I and II physical condition Age between 18-65 years 18 years 65 years Both Patient refusal to participate Neuromuscular diseases (eg myopathy, myasthenia gravis) Hematological diseases, bleeding or coagulation disorders Local skin infection and sepsis at the block site Known hypersensitivity to study drugs Morbid obesity (BMI > -35.7 History of alcoholism or drug addiction Any uncompensated systemic disease (cardiovascular, respiratory, metabolic, neurological and endocrine) Other mental or emotional problems that may invalidate informed consent. Patients will be screened by a preoperative care nurse. Potentially eligible individuals will be directed to investigators for screening and additional information. Sleep apnea or any other sleep disorder G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Patients received 17 ml of 0.25% bupivacaine + 3 ml of 0.9% saline in a total volume of 20 ml on each side. Intervention group: Patients received 17 ml of 0.25% bupivacaine + dexamethasone (4 mg) diluted in 3 ml of 0.9% saline in a total volume of 20 ml on each side. Intervention group: Patients received 17 ml of 0.25% bupivacaine + dexmedetomidine (1 µg/kg) diluted in 3 ml of 0.9% saline in a total volume of 20 ml on each side. Severity of patients' pain. Timepoint: zero, 2, 4, 6, 12 and 24 hours after the operation. Method of measurement: Visual Analogue Scale. Sedation score. Timepoint: zero hours 2, 4, 6, 12 and 24 after the operation. Method of measurement: Reverse Observer Assessment Scale of Consciousness/Sedation (OAA/S). Mazandaran University of Medical Sciences Approved 2023-02-01 Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)