Effect of ultra-low dose Naloxone on pain intensity after laparoscopic cholecystectomy surgery

Effect of ultra-low dose Naloxone on pain intensity after laparoscopic cholecystectomy surgery

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 60 patients. In order to randomize, the block randomization method will be used.

In this research, all patients requiring laparoscopic cholecystectomy surgery, referred to Rasoul Akram Hospital in Tehran, will be included in the study. Patients will be randomly divided into 2 groups based on blocks of 4. The sample size for each study group is 30 people. A total of 60 patients will be examined. Patients, surgeon and data analyst will be blinded.

Inclusion criteria: Candidate for non-emergency laparoscopic cholecystectomy surgery, Age between 30-65 years. Non-entry criteria: History of psychological illness, pregnant women, Abuse of alcohol or drugs.

After the surgery, a PSA pump will be used for pain control for all patients. Intervention group: The internal composition of the PSA pump includes 20 mg of morphine mg/ml and naloxone at a dose of 0.25 μg/kg/h, it will be up to 100 cc (the total volume of the PSA pump). Control group: The internal composition of the PSA pump includes 20 mg of morphine mg/ml and , the rest of it will be up to 100 cc of normal saline inside the PCA pump. (the total volume of the PSA pump).

Severity of patients' pain

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.

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.