Comparison of two very low doses of naloxone in combination with ropivacaine on the onset ,severity and duration of axillary block in patients with hand and forearm surgery

Comparison of two very low doses of naloxone in combination with ropivacaine on the onset ,severity and duration of axillary block in patients with hand and forearm surgery

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 75 patients. In order to randomize, the block randomization method will be used.

In this research, all patients requiring hand and forearm surgery, referred to Rasoul Akram Hospital in Tehran, will be included in the study. Patients will be randomly divided into 3 groups based on blocks of 6. The sample size for each study group is 20 people. A total of 60 patients will be examined. Patients, surgeon and data analyst will be blinded.

Inclusion criteria: Candidate patients for hand and forearm surgery, Age between 18-70 years. Exclusion criteria: Anemia, sensitivity to local anesthetic drugs, congenital and acquired neuromuscular diseases, history of seizures, drug addiction, heart diseases and any digestive system disorders.

Patients are divided into three groups of 20 and undergo axillary block guided by ultrasound and neurostimulator. In the first intervention group, axillary block is performed using ropivacaine in combination with naloxone 4 micrograms. In the second intervention group, axillary block is performed using ropivacaine combined with naloxone 0.4 micrograms. In the control group, axillary block is performed using ropivacaine combined with normal saline (placebo).

Pain score; The amount of drug use

Patients will be randomly divided into 3 groups. The randomization tool will be a random sequence generation software called SIS. In addition to simple randomization, these random sequence generation softwares are capable of generating random sequences using the 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, 6 blocks will be formed and in each block 2 people from intervention group 1, 2 people from intervention group 2 and 2 people will be placed in the control group. A total of 10 blocks will be considered to reach the sample size. Random allocation concealment will be done using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. the door At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

The surgeon and the patients will be unaware and blind of the type of drug used in the axillary block. To hide similar and identical sera, it was used without drug name label and only with code. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will not know which treatment will be provided in that group. Patients will be assigned to one of three groups using a random number table. The surgeon also knows that axillary block will be performed by three different methods for the patients, but he will not know which method will be performed for each patient. The person in charge of data collection, the analyst, and the outcome evaluator will collect and analyze the information based on groups 1, 2, and 3, and will not know the type of treatment provided in the groups and will be kept blind.