Evaluation of the effect of local injection of dexamethasone with bupivacaine at pre-peritoneal laparoscopic ports on laparoscopic complications after laparoscopic cholecystectomy a randomized controlled clinical trial.

Study the effect of dexamethasone and bupivacaine pre-peritoneal injection at the site of laparoscopic ports, on complications after laparoscopic cholecystectomy

Randomized parallel phase 3 placebo-controlled triple-blinded clinical trial study

In order to evaluate the effect of bupivacaine with and without dexamethasone on pain after laparoscopic cholecystectomy, in the operating room by one of the trained technicians without informing any involved researcher and investigator, in one group of bupivacaine + dexamethasone and in the other group bupivacaine+ the same amount of normal saline is prepared and injected. The severity of postoperative pain, the rate of opium usage for pain control, and the rates of nausea and vomiting are investigated.

The inclusion criteria are all patients undergoing laparoscopic cholecystectomy diagnosed with biliary colic or chronic cholecystitis. Criteria for not including patients in our study are the diagnosis of acute cholecystitis along with findings such as leukocytosis and high ESR and CRP, gangrene, empyema and evidence of bile in the abdominal cavity during surgery, known allergy to local anesthetics, open surgery and diabetic patients and those with dirty wounds and open cholecystectomy.

In the intervention group, the dose of dexamethasone is 0.2 mg per kg of body weight. It is divided into four parts, and each part is injected around each trocar. For bupivacaine, 7 mg is injected at the lower ports and 3 mg at the upper ports. For a placebo, the same amount of normal saline based on the dexamethasone formula is mixed and injected.

The severity of postoperative pain, rates of opium usage for pain control, nausea, and vomiting

Trial ending and updating information

Patients will be randomly divided into two groups using the computer random-generated number method. This random distribution of patients will be done by an independent computer programmer using www.randomization.com.

On the day of surgery, one of the operating room technicians trained according to the instructions and based on the site www.randomization.com prepares the medicine for the group in which the patient is accidentally placed and then the surgeon injects it only without notice to the relevant place. Dexamethasone and bupivacaine are injected into a syringe, and to hide the volume of the drug, the syringes are covered with a dark coating and the syringe is identified only based on groups A and B. Slowly The patient and the data collector and the safety and data monitoring committee also do not know what the drug was.