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IRCT20190511043550N4 IRCT 2022-03-06 Shiraz University of Medical Sciences Comparison between intraperitoneal versus transversus abdominis plane block by ropivacaine for postoperative analgesia in laparoscopic cholecystectomy Comparison between intraperitoneal versus transversus abdominis plane block by ropivacaine for postoperative analgesia in laparoscopic cholecystectomy 2022-02-14 anticipated 68 Complete https://irct.ir/trial/61493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. Samples (68 patients) by random block method with blocks of 4 and 8 including 34 participants in two treatment groups, intervention group 1 with 34 participants and in intervention group 2 Also, with 34 participants, will be identified using a table of random numbers extracted from the relevant software. Matching will be done then based on the obtained blocks and the sequence of drug allocation in the operating room will be injected to the people. This study is a double-blind study, Blinding description: The drugs are prepared by an anesthesiologist who does not know how to perform the study and is delivered to the anesthesiologist in the operating room. Recovery will not give them any information and thus the patient, recovery nurse and inpatient ward, and data analyzer will be referred to the blind study. 2-3 laparoscopic cholecystectomy. Intervention 1: Intervention group: (Group I) 30 ml of 0.2% ropivacaine (made by Multeni company) enters the peritoneal space through the trocar. Intervention 2: Intervention group:2: (Group T) after the end of surgery and before the patient woke up, under the guidance of ultrasound transversus abdominis block (TAP block) by anesthesia with 30 ml of ropivacaine 0.2% (made by Multeni company) (15 ml in Each side) is done. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public paria dinparvar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3630 4312 pariadin۶۴@gmail.com Shiraz University of Medical Sciences scientific Ashkan panah
Khalili st
shiraz Iran (Islamic Republic of) ۱۴۳۳۶۷۱۳۴۸ +98 71 3629 1470 panah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Obtaining informed consent Patient aged 18 to 65 years with ASA class I & II who is a candidate for laparoscopic cholecystectomy 18 years 65 years Both Conductive heart diseases that prevent the use of local anesthetics. Patients taking painkillers for other chronic pain Patients with a history of drug use or alcoholism BMI> 35 Patients who are unable to express pain score for any psychological reason Previous abdominal surgery Allergy to any local anesthetic Treatment - Drugs Treatment - Drugs Intervention group: (Group I) 30 ml of 0.2% ropivacaine (made by Multeni company) enters the peritoneal space through the trocar Intervention group:2: (Group T) after the end of surgery and before the patient woke up, under the guidance of ultrasound transversus abdominis block (TAP block) by anesthesia with 30 ml of ropivacaine 0.2% (made by Multeni company) (15 ml in Each side) is done. Post operative pain. Timepoint: The patient's pain is measured at 0, 2, 4, 8, 12, 18 and 24. Method of measurement: The patient's pain is measured, and recorded by the recovery staff based on the VAS criteria or scoring of pain sensation and by the ward staff after discharge from the recovery. Shiraz University of Medical Sciences Approved 2021-12-20 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)