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IRCT20110530006640N9 IRCT 2022-09-11 Tehran University of Medical Sciences The effect of bupivacaine on post laparoscopic pain in laparoscopic hysterectomy withe three way of injection ( subcutaneous in trocar site and intraperitoneal and posterior transverses abdominis plan block under laparoscopic guide ) The effect of subcutaneous in trocar site and intraperitoneal and posterior transverses abdominis plan block under laparoscopic guide with bupivacaine on post laparoscopic pain in laparoscopic hysterectomy 2022-08-07 anticipated 95 Complete https://irct.ir/trial/64668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For the randomization process, the balance block randomization method is used using STATA software. To ensure that the randomization process of people in the groups remains hidden, the randomized sequence is kept with one of the project researchers, who is part of the selection team. Patients and carrying out the intervention process and evaluating the outcome are not, Blinding description: For the randomization process, the balance block randomization method is used using STATA software. To ensure that the randomization process of people in the groups remains hidden, the randomized sequence is kept with one of the project researchers, who is part of the selection team. Patients and carrying out the intervention process and evaluating the outcome are not. The study is conducted in a double-blind manner, in such a way that none of the patients and the pain evaluator know about the method of analgesia after laparoscopic hysterectomy surgery. Analgesia is injected by laparoscopic fellowship doctors half an hour before the end of anesthesia induction. Procedure selection envelopes are with the operator of the operating room, and one envelope is randomly delivered to the laparoscopic fellowship for anesthesia. 3 Pain after laparoscopic hysterectomy surgery. Intervention 1: Intervention group: subcutaneous injection of 10cc bupivacaine 0.25% /Heavy under trocar sites. Intervention 2: Intervention group: 10cc Bupivacaine 0.25% /Heavy injection into the Transvers abdominis plan block. Intervention 3: Intervention group:10cc Bupivacaine 0.25%/Heavy intraperitoneal injection. Intervention 4: Control group: No injection of bupivacaine 0.25% to any of the intervention methods. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zahra Asgari
Arash Hospital, Resalat highway, Farjam street
Tehran Iran (Islamic Republic of) 1598116539‎ +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Zahra Asgari
Arash Hospital, Rashid street ,Resalat highway
Tehran Iran (Islamic Republic of) 1598116539‎ +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All candidates for elective laparoscopic hysterectomy surgery referred to Arash Hospital Have a good general health level based on ASA Grade 1&2. Candidates for hysterectomy due to benign disease. no limit no limit Female Patients who suffered from chronic pelvic pain (non menstrual pain of 6 or more months) Pregnancy Allergy to Bupivacaine hydrochloride Emergency surgeries Execution of additional vaginal procedures Surgeries performed for following indication :active pelvic infection, ectopic pregnancy , or malignancy Patients with conversion laparoscopy to laparotomy and intraoperative diagnosis of malignancy (confirmed by frozen section pathology) G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: subcutaneous injection of 10cc bupivacaine 0.25% /Heavy under trocar sites Intervention group: 10cc Bupivacaine 0.25% /Heavy injection into the Transvers abdominis plan block Intervention group:10cc Bupivacaine 0.25%/Heavy intraperitoneal injection Control group: No injection of bupivacaine 0.25% to any of the intervention methods Abdominal pain and shoulder pain. Timepoint: 2-4 hours , 8 h , 12 h , 24 h , after surgery. Method of measurement: With Visual Analogue Scale. Tehran University of Medical Sciences Approved 2022-04-06 Ethics committee of school medicine,Tehran University of Medical Sciences Tehran University of Medical Science, Poursina St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)