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IRCT20180922041084N7 IRCT 2022-09-07 Shiraz University of Medical Sciences Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods interpersonal instillation of normal saline, ropivacaine, sodium bicarbonate and ropivacaine-sodium bicarbonate combination Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods interpersonal instillation of normal saline, ropivacaine, sodium bicarbonate and ropivacaine-sodium bicarbonate combination 2022-09-21 anticipated 200 Complete https://irct.ir/trial/64770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, 200 patients were randomly divided into 25 blocks with a size of 8 for four groups using the permutation random block method. Blocking and allocating the sequence will be done to hide it by a person not involved in the research, employing identical non-transparent envelopes. Then, based on the obtained blocks and in the order of the allocation sequence, the drugs will be given to the patients. This study is double-blind. Total sample size = number of groups * repetition of the number of groups in each block * number of blocks And it has been blocked through the following site:https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: In this study, The drugs are prepared by an anesthetist who is unaware of how the study is conducted and delivered to the anesthesiologist in the operating room, who is also unaware of how the study is completed. In this way, the patient, the anesthesia resident, and the person who prepares the medicine are not aware of the study group's allocation and are blinded to the study. 2-3 Laparoscopic cholecystectomy. Intervention 1: Intervention group1: group A patients; will receive 10 ml of ropivacaine 0.5% (Made by the company Fresenius Kabi, Austria) in the areas below the right and left diaphragm and in the gallbladder bed. Intervention 2: Intervention group2: In group B, they will receive ropivacaine 0.5 with a dose of 10 ml along with sodium bicarbonate solution(Made by Sopa company Iran) with a dose of 50 ml of 7.5% in 1000 ml of normal saline at a temperature of 37 degrees Celsius. Intervention 3: Intervention group3: In group C patients, sodium bicarbonate solution with a dose of 50 ml of sodium bicarbonate 7.5 in 1000 ml of normal saline at 37 degrees Celsius for 2 to 5 minutes is used to wash the abdomen, and after 5 minutes the liquid will be suctioned. Intervention 4: Intervention group4: Group D, which will undergo intraperitoneal washing with normal saline solution in the amount of 1000 ml alone. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Asghar Rayat zade
Anesthesiology Department, Faghihi Hospital, Zand Street
SHIRAZ Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 dr.rayat@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Hossein Eghbal
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 mheghbal@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent People aged 18 to 60 are eligible candidates for laparoscopic cholecystectomy surgery 18 years 60 years Both History of heart diseases Hypertension Bradycardia Simultaneous presence of peripheral neuropathy pregnant women Patients who are addicted to drugs and stimulants K82.9 Disease of gallbladder, unspecified Treatment - Surgery Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group1: group A patients; will receive 10 ml of ropivacaine 0.5% (Made by the company Fresenius Kabi, Austria) in the areas below the right and left diaphragm and in the gallbladder bed. Intervention group2: In group B, they will receive ropivacaine 0.5 with a dose of 10 ml along with sodium bicarbonate solution(Made by Sopa company Iran) with a dose of 50 ml of 7.5% in 1000 ml of normal saline at a temperature of 37 degrees Celsius. Intervention group3: In group C patients, sodium bicarbonate solution with a dose of 50 ml of sodium bicarbonate 7.5 in 1000 ml of normal saline at 37 degrees Celsius for 2 to 5 minutes is used to wash the abdomen, and after 5 minutes the liquid will be suctioned. Intervention group4: Group D, which will undergo intraperitoneal washing with normal saline solution in the amount of 1000 ml alone. Postoperative pain. Timepoint: Times 0-1-2-4-8-12 and 24 hours after the operation. Method of measurement: VAS (Visual Analog Scale) & VRS(Verbal Rating Scale) numerical scoring scale. Shiraz University of Medical Sciences Approved 2022-01-24 Ethics Committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)