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IRCT20210502051161N1 IRCT 2021-05-23 Hamedan University of Medical Sciences The effect of standard pressure and low pressure of pneumoperitoneum with surgery site suction on pain intensity in laparoscopic cholecystectomy patients Comparison of the effect of standard pressure versus low pressure pneumoperitoneum with surgery site suction on the severity of shoulder pain in patients undergoing laparoscopic cholecystectomy 2021-05-22 anticipated 70 Complete https://irct.ir/trial/56031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: For randomization, a simple randomization method is used. Using coin tossing, the intervention group is determined, so that if the side is lined, patients are in the intervention group, and if the side is not lined, patients are in the group. Will be controlled. The unit is individual randomization. The method of hiding random allocation in this study is the SNOSE method. In this method, first a random sequence is performed, then based on the sample size of the research, a number of envelopes with aluminum wrappers are prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelope. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface of the envelopes. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed. In the implementation phase of the random allocation process of this study, cases such as the individual who created the random sequence, the person who examined the participants in terms of inclusion and exit criteria, and the participants who studied and participated in the study. It is intended that three separate individuals perform the randomization process without being aware of the actions of other researchers, Blinding description: Patients are told about standard pneumoprotein pressure and low pneumoperitoneum pressure, but are not aware of which group they belong to. N/A Laparoscopic cholecystectomy. Intervention 1: Use of carbon dioxide gas with 99% purity made by Qazvin Oxygen Company, gas pressure: 8 to 11 mm Hg, use of operation area suction. Intervention 2: Control group: Use of carbon dioxide gas with 99% purity made by Qazvin Oxygen Company, gas pressure: 12-14 mm Hg. 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 There is no more information
public Hamidreza Nejati
Shahid Fahmideh St., in front of People Park, Hamadan University of Medical Sciences
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3525 0182 hamidrezaa891425@gmail.com Hamedan University of Medical Sciences scientific Doctor Behzad Imani
Shahid Fahmideh St., in front of People Park, Hamadan University of Medical Sciences
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3525 0182 behzadiman@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having gallstones without serious complications Elective laparoscopic cholecystectomy Age between 18 and 70 years Having ASA1,2 Having informed consent to participate in the study 18 years 70 years Both Having a history of major abdominal surgery Having ASA3 Pregnancy and breastfeeding Drug addiction and the use of strong anti-anxiety drugs Coagulation problems Conscious dissatisfaction to participate in the study K80.0 Calculus of gallbladder with acute cholecystitis Prevention Prevention Use of carbon dioxide gas with 99% purity made by Qazvin Oxygen Company, gas pressure: 8 to 11 mm Hg, use of operation area suction Control group: Use of carbon dioxide gas with 99% purity made by Qazvin Oxygen Company, gas pressure: 12-14 mm Hg Severe shoulder and abdominal pain after surgery. Timepoint: Two, six, twelve and twenty-four hours after the operation. Method of measurement: 10 point pain ruler. Rate of request for postoperative analgesic. Timepoint: Six, twelve and twenty-four o'clock after the operation. Method of measurement: The amount and dose of medication used for the patient. Hamedan University of Medical Sciences Approved 2021-05-02 Hamedan University of Medical Sciences Shahid Fahmideh, in front of People's Park hamedan Hamadan Iran (Islamic Republic of)