IRCT20230424057986N1 IRCT 2023-05-18 Iran University of Medical Sciences Effect of ultra-low dose Naloxone on pain Effect of ultra-low dose Naloxone on pain intensity after laparoscopic cholecystectomy surgery 2023-06-05 anticipated 60 Complete https://irct.ir/trial/70018 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups. The randomization tool will be a random sequence generation software called SAS. In addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 4 blocks will be formed and in each block, 2 people from intervention group and 2 people in control group will be placed. A total of 15 blocks will be considered to reach the sample size. The blocks contain numbers, odd numbers represent the intervention group and even numbers represent the control group. Their order will be determined by the software initially. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards respectively will be placed in the envelopes. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: Patients will be blinded to the type of treatment. To hide, similar and identical serums, were used without drug name label and only with code. Patients will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which treatment will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind. 3 Cholecystitis. Intervention 1: Intervention group: Intervention group: Patients with a specific anesthesia protocol that includes midazolam 0.1 mg/kg (manufacturer: Abu Rayhan), fentanyl 3 μg/kg (manufacturer: Norman S A), nesdonal 5 mg/kg (manufacturer: Co. Jaber Eban Hayan Pharmaceuticals), atracurium 0.1 mg/kg (manufacturer: Behin Tamin Roza Med Co.) at intervals of 20 to 40 minutes, and during anesthesia with isoflurane 1 MAC, they will be under general anesthesia. After the surgery, a PSA pump (Manufacturer: Pouyan Teb Tajhiz Asia Co., Ltd.) will be used for pain control for all patients. The internal composition of the PSA pump in the intervention group includes 20 mg of morphine mg/ml (manufacturer: Daro Pakhsh) and naloxone at a dose of 0.25 μg/kg/h (manufacturer: Tolid Daroo), it will be up to 100 cc (the total volume of the PSA pump). Intervention 2: Control group: Patients with a specific anesthesia protocol that includes midazolam 0.1 mg/kg (manufacturer: Abu Rayhan), fentanyl 3 μg/kg (manufacturer: Norman S A), nesdonal 5 mg/kg (manufacturer: Co. Jaber Eban Hayan Pharmaceuticals), atracurium 0.1 mg/kg (manufacturer: Behin Tamin Roza Med Co.) at intervals of 20 to 40 minutes, and during anesthesia with isoflurane 1 MAC, they will be under general anesthesia. After the surgery, a PSA pump (Manufacturer: Pouyan Teb Tajhiz Asia Co., Ltd.) will be used for pain control for all patients. The internal composition of the PSA pump in the control group includes 20 mg of morphine mg/ml (manufacturer: Daro Pakhsh) and the rest of it will be up to 100 cc of normal saline (manufacturer: Samen Pharmaceuticals) inside the PCA pump. (the total volume of the PSA pump). 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 After completing the work and consulting with all the writers and executive agents, I will make a decision.