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 transverse abdominal plane block on pain intensity, hemodynamic parameters and other outcomes after laparoscopic cholecystectomy surgery.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 111 patients. Excel software was used for Blocked Randomization.

It will be carried out in the Imam Khomeini Educational-Therapeutic Hospital of Sari in Mazandaran province. In this study, the patient and the final evaluator will not know about the allocation method (double-blind).

Physical status of ASA class I and II, age between 18-65 years and exclusion conditions: patient refusal to participate. Neuromuscular diseases (for example, myopathy, myasthenia gravis). Hematological diseases, bleeding or coagulation disorders. Local skin infection and Sepsis at the site of the block. Known hypersensitivity to the study drugs. Morbid obesity (BMI > 35), sleep apnea or any other sleep disorder, history of alcoholism or drug addiction, any uncompensated systemic disease, other mental or emotional problems.

Control group = patients will receive 17 ml of 0.25% bupivacaine + 3 ml of 0.9% saline in a total volume of 20 ml per side Dexamethasone group: patients will receive 17 mL of 0.25% bupivacaine + dexamethasone (4 mg) diluted in 3 mL of 0.9% saline in a total volume of 20 mL per side. Dexmedetomidine group = patients will receive 17 ml bupivacaine 0.25% + dexmedetomidine (1 µg/kg) diluted in 3 ml saline 0.9% in a total volume of 20 ml on each side.

Pain intensity, nausea, sedation

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.

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