A Comparison effect of ultrasound bilateral TAP-Block, before start and after the end of surgery, on pain relief in patients underwent laparoscopic cholecystectomy surgery

A Comparison effect of ultrasound bilateral TAP-Block, before start and after the end of surgery, on pain relief in patients underwent laparoscopic cholecystectomy surgery

Clinical trial with parallel groups, double-blind, randomized, phase2 on 60 patients. The rand function of Excel software was used for randomization.

Patients referred to Imam Khomeini Hospital in Sari were blinded by a random double-blind method. In this method, a random sequence is first created using the mentioned software, then based on the sample size of the study, a number of envelopes with aluminum wrappers are prepared and each of the random sequences created is recorded on a card, and the card are placed in the envelopes in order. Based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

Age 20 to 60 years, physical condition according to ASA, I to II, consent to participate in the study, elective cholecystectomy, no history of opioid use or tolerance to opioid or alcohol, no coagulopathy, no history of sensitivity to bupivacaine, BMI less than equal 35. Absence of neuromuscular disease such as myelopathy and myasthenia gravis, absence of sleep apnea or any other sleep disorder, absence of any uncompensated systemic disease such as cardiovascular, respiratory, metabolic, neurological and endocrinological diseases, absence of History of psychiatric problems, not taking psychiatric drugs, exclusion criteria, conversion of laparoscopic cholecystectomy to open cholecystectomy, uncontrolled bleeding during surgery.

The group receiving TAP-Block before surgery (Pre-Surgery) The group receiving TAP-Block after surgery (Post-Surgery)

Severity of pain-nausea and vomiting

Random allocation by the method of variable 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.

In this design, blinding is by random double-blind method. In this way, the person evaluating the patient and the patient himself do not know about the groups to which the patient has been assigned. 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.