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IRCT20201006048950N1 IRCT 2020-12-08 Arak University of Medical Sciences effect of irrigation- suction system on the reduction of postoperative pain in patients Comparative study of the effect of irrigation- suction system with 2% lidocaine during surgery on the reduction of postoperative pain in patients undergoing laparoscopic cholecystectomy in 1999 2021-02-21 anticipated 70 Complete https://irct.ir/trial/51770 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after obtaining patient satisfaction, using random permutation block method, patients were randomly assigned to two groups of suction-irrigation with normal saline composition of 0.9% and suction irrigation with lidocaine combination of 2%. First, the name of each suction-irrigation method is an English letter such as A and B, and the randomization list will be a sequence of these two letters. Therefore, the person making the list is not aware of the method. In the random permutation block method, double blocks AB and BA are used. Randomization unit is a block. The lead researcher who conducts the study is only aware of the next patient's treatment and proceeds accordingly. Finally, 35 people are examined in each group, which includes a total of 70 patients, Blinding description: This study is of the one-blind type. The patient is fully aware that he or she has participated in a study with two methods of suction irrigation and completes the informed consent form. But the patient does not know which irrigation suction method was used for him. Therefore, the patient is blinded.The lead researcher and her colleagues could not be blinded due to the implementation of irrigation suction methods. N/A Cholecystitis. Intervention 1: Intervention group: Used 2%Lidocaine And 0.9%Sodium Chloride Serum : In the intervention group, the operation locale was Irrigated with 100 cc of 0.9% normal saline solution containing 2 mg / kg 2% lidocaine for 5-10 minutes and then the entire fluid was aspirated by the Suction-Irrigation Device as much as possible. Intervention 2: Control group: Just used 0.9%Sodium Chloride Serum. 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 we haven't decided yet - the release schedule is still unknown
public Abolfazl Mohtarami
Basij Sq
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3417 3520 daneshkadeha@arakmu.ac.ir Arak University of Medical Sciences scientific Mahboobeh Khosravani
Basij square,sardasht street.medical university of arak.faculth of nursing.
Markazi Iran (Islamic Republic of) ۶۹۴۱-۷-۳۸۴۸۱ +98 86 3417 3505 mahboobkhosravani@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients with chronic cholecystitis are candidates for elective laparoscopic cholecystectomy 20 years 70 years Both Taking medications that can affect patients' postoperative pain K80.0 cholecystitis Treatment - Drugs Treatment - Other Intervention group: Used 2%Lidocaine And 0.9%Sodium Chloride Serum : In the intervention group, the operation locale was Irrigated with 100 cc of 0.9% normal saline solution containing 2 mg / kg 2% lidocaine for 5-10 minutes and then the entire fluid was aspirated by the Suction-Irrigation Device as much as possible. Control group: Just used 0.9%Sodium Chloride Serum Pain. Timepoint: 0, 6, 12, 24 hours after surgery. Method of measurement: 10 point pain ruler/ Select descriptive smileys. Arak University of Medical Sciences Approved 2020-10-06 Ethics committee of Arak University of Medical Sciences Arak University of Medical Scienses, Dr Qarib Blvd., Basij Sq, Arak City Arak Markazi Iran (Islamic Republic of)