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IRCT20170515033986N5 IRCT 2023-08-07 Shahid Beheshti University of Medical Sciences A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided in laparoscopic cholecystectomy 2023-09-22 anticipated 100 Complete https://irct.ir/trial/71453 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (100 patients), 25 blocks of 4 will be used, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the main investigator, who will assess the outcomes, will blind to patient's allocation in one of the intervention groups. Blocks will be performed by an anesthesiologist and surgeon (other than the outcome assessor). So, the list of computer-generated numbers will be given to the anesthesiologist. The physician will assign patients to groups based on computer-generated numbers. Finally, the name of groups will be label with the letters A and B. 3 Analgesia after laparoscopic cholecystectomy surgery. Intervention 1: Intervention group:In group one after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under ultrasound guidance by an anesthesiologist. Intervention 2: Intervention group: In group two after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under laparoscopic guidance by a surgeon. 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 Confidentiality of patient information
public Dr.Nazli Karami
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3345 7286 karami.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr.Nazli Karami
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3245 7286 karami.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients undergoing laparoscopic cholecystectomy Age between 18 and 80 years Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II) 18 years 80 years Both Drug abusers Body mass index above 30 kg/m2 Having previous abdominal surgeries History of psychological and neurological diseases Pregnancy MG31.2 Acute postoperative pain, not elsewhere classified Treatment - Surgery Treatment - Surgery Intervention group:In group one after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under ultrasound guidance by an anesthesiologist. Intervention group: In group two after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under laparoscopic guidance by a surgeon. Duration of analgesia. Timepoint: From the administration of the block to the administration of the first analgesic drug up to 24 hours after the surgery. Method of measurement: Minute. Dose of analgesic drug (Morphin). Timepoint: Up to 24 hours after the surgery. Method of measurement: Milligram. Pain severity. Timepoint: 2, 6, 12 and 24 hours after the surgery. Method of measurement: NRS scale (Numerical Rating Scale). Heart rate. Timepoint: Before and 2, 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring. Systolic blood pressure. Timepoint: Before and 2, 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring. Diastolic blood pressure. Timepoint: Before and 2, 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring. Shahid Beheshti University of Medical Sciences Approved 2023-07-02 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences., Erabi Ave., Daneshjou Blvd., Tehran., Iran. Tehran Tehran Iran (Islamic Republic of)