The Effect of Single Prophylactic Dose of Pregabalin on Pain Management and Opioids After Cholecystectomyin Patients Referred to Bo Ali Hospital in Tehran

The Effect of Single Prophylactic Dose of Pregabalin on Pain Management and Opioids After Cholecystectomyin Patients Referred to Bo Ali Hospital in Tehran

The current study is a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups and phase 2-3, and will be conducted with the participation of 80 patients who are candidates for laparoscopic cholesystemectomy surgery.

This randomized and double-blind trial study will be conducted with the participation of 80 patients who are candidates for laparoscopic cholecystectomy surgery; Pregabalin tablets will be given to patients in the intervention group before surgery, and placebo will be given to the patients in the intervention group, and the pain intensity will be compared between them. The participants and the data analyst will be blinded during the study.

Inclusion criteria include: candidates for laparoscopic cholecystectomy, class I and II according to ASA and consent to participate in the study, and exclusion criteria include: sensitivity to pregabalin, conversion of surgery from laparoscopic to open surgery, and body mass index. There will be more than 40.

In this study, a randomized and double-blind clinical trial with the participation of 80 patients (intervention group = control group = 40 people) candidates for laparoscopic cholecystectomy, pain intensity between the group receiving pregabalin (300 mg one hour before the start of anesthesia) with The group that does not receive medicine (placebo group: receiving a pill of the same shape and color as pregabalin) will be compared.

Pain

In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1:BBAA and block 2:AABB and block 3:ABAB and block 4:BABA and block 5:ABBA and block6:BAAB we need 20 blocks for 80 people, these blocks are random in the software environment (version 2.0 (RandomAlloc.exe)) allocation software will be defined so that the number of 20 blocks of 4 will be defined in this software, this software is capable of generating a random sequence using the block method, then we choose from numbers one to six; For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right, and finally to two intervention groups (group A) and group Control (group B) were divided.

The thesis results analyst who analyzed the expected outcome and also the participants remained unaware of the type of procedure performed and were blind during the study; Therefore, this study was conducted in a double-blind manner.