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IRCT20211008052699N1 IRCT 2021-11-29 Esfahan University of Medical Sciences Evaluation of dexamethasone injection on complications after gallbladder surgery 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. 2021-11-30 anticipated 96 Complete https://irct.ir/trial/59302 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Condition 1: Chronic cholecystitis. Condition 2: Postprocedural pain. Intervention 1: Intervention group 1: After induction of general anesthesia and surgery, a peritoneal injection will be performed at the incision site of the trocars under the direct guidance of a laparoscopic camera with No. 18 branul. In the "bupivacaine + dexamethasone" group, 7 mg bupivacaine is injected at the lower ports and 3 mg bupivacaine at the upper ports. The dose of dexamethasone is then determined based on the patient's weight at 0.2 mg per kg and divided into four parts and each part is injected at the site of a port. Intervention 2: For intervention group 2: In the bupivacaine group alone, 7 mg bupivacaine will be injected at the lower ports and 3 mg bupivacaine at the upper ports. For the placebo, based on the formula used for dexamethasone and body weight, sterile injectable normal saline is used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data are not completed yet.
public Mohammad Eslamian
Soffeh Blvd, Al-Zahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mr.esl67@gmail.com Esfahan University of Medical Sciences scientific Mohammad Eslamian
Soffeh Blvd, Al-Zahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mr.esl67@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Laparoscopic cholecystectomy with diagnosis of biliary colic or chronic cholecystitis 18 years no limit Both Acute cholecystitis Presence of leukocytosis or high ESR, CRP Gangrene, empyema and evidence of bile in the abdominal cavity during surgery Known allergies to local anesthetics History of chronic pain following the use of common narcotics Open cholecystectomy Patients with immunodeficiency and diabetes Cases that have dirty wounds during the operation K81.1 G89.18 Chronic cholecystitis Other acute postprocedural pain Treatment - Drugs Placebo Intervention group 1: After induction of general anesthesia and surgery, a peritoneal injection will be performed at the incision site of the trocars under the direct guidance of a laparoscopic camera with No. 18 branul. In the "bupivacaine + dexamethasone" group, 7 mg bupivacaine is injected at the lower ports and 3 mg bupivacaine at the upper ports. The dose of dexamethasone is then determined based on the patient's weight at 0.2 mg per kg and divided into four parts and each part is injected at the site of a port. For intervention group 2: In the bupivacaine group alone, 7 mg bupivacaine will be injected at the lower ports and 3 mg bupivacaine at the upper ports. For the placebo, based on the formula used for dexamethasone and body weight, sterile injectable normal saline is used. Pain intensity based on VAS the first 24 hours after surgery. Timepoint: 24 hours after the surgery. Method of measurement: Visual analog scale. The need for opium and analgesics. Timepoint: 24 hours after the surgery. Method of measurement: Medical records. Frequency of nausea, vomiting within 24 hours after surgery. Timepoint: 24 hours after the surgery. Method of measurement: Medical records. Esfahan University of Medical Sciences Approved 2021-10-03 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical sciences., Hezarjarib St., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)