]>
IRCT20180325039148N1 IRCT 2018-05-17 Zanjan University of Medical Sciences Effect of abdominal wall block on post cholecystectomy pain TAP Post-operative Analgesic efficacy of ultrasound-guided sub costal transversus abdominis plane(TAP) block for laparoscopic Cholecystectomy 2018-06-20 anticipated 60 Complete https://irct.ir/trial/30831 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks will be performed for this trial.Each block has 4 samples,two TAP block and two control with different orders, Blinding description: All patients(control and intervention groups) after giving necessary explanations will be enrolling in abdominal block group or control group .The anesthetist who is responsible for evaluating of outcomes ,will be blinded about doing or not doing of abdominal plane block. N/A Sub costal Transverus Abdominal Plane Block. Intervention 1: Intervention group:This randomized study will be enrolled patients with American Society of Anesthesiologists (ASA) physical status I–II aged 18–65 years, undergoing laparoscopic cholecystectomy at Zanjan mousavi Research and Training Hospital.The operation will be done under General Anesthesia. TAP GROUP:At the end of the surgery,under ultrasound guidance, 0.2% bupivacaine 20 ml will be injected between rectus abdominis and transverse abdominis at subcostal region.This block will be done bilaterally. IN intervention and control groups,the pain severity by visual analogue scale(VAS),nausea and vomiting incidence,need to mepridine and metocloparmide will be evaluated. Time frame of assessments :during recovery room stay,at 4h,8h,12h and 24h.All patients will be evaluated before surgery and also will be told them about the VAS,where 0=no pain and 10=worst imaginable pain.In both groups ,all patients and the evaluating person will not awared of being or not being intervention.For nausea :0=none,1=mild,2=moderate,3=sever. Intervention 2: Control group:There wont be any special intervention or TAP block. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no information.
public Saeed Jalili
Gavazang Blvd.,moosavi hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 jalilis45@zums.ac.ir Zanjan University of Medical Sciences scientific Saeed Jalili
Gavazang Blvd.,moosavi hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 jalilis45@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients within 20-60 years undregoing laparoscopic Cholecystectomy Body Mass Index below 30 20 years 65 years Female pregnancy Allergy to local anesthetics sepsis Addiction Treatment - Other Treatment - Other Intervention group:This randomized study will be enrolled patients with American Society of Anesthesiologists (ASA) physical status I–II aged 18–65 years, undergoing laparoscopic cholecystectomy at Zanjan mousavi Research and Training Hospital.The operation will be done under General Anesthesia. TAP GROUP:At the end of the surgery,under ultrasound guidance, 0.2% bupivacaine 20 ml will be injected between rectus abdominis and transverse abdominis at subcostal region.This block will be done bilaterally. IN intervention and control groups,the pain severity by visual analogue scale(VAS),nausea and vomiting incidence,need to mepridine and metocloparmide will be evaluated. Time frame of assessments :during recovery room stay,at 4h,8h,12h and 24h.All patients will be evaluated before surgery and also will be told them about the VAS,where 0=no pain and 10=worst imaginable pain.In both groups ,all patients and the evaluating person will not awared of being or not being intervention.For nausea :0=none,1=mild,2=moderate,3=sever Control group:There wont be any special intervention or TAP block. Pain rating in Visual Analogue Scale. Timepoint: During recovery,At 4h,8h,12h,24h after surgery. Method of measurement: Visual Analogue Scale questionnaire. Post operative need to opioid analgesic. Timepoint: During recovery,At 4h,8h,12h,24h after surgery. Method of measurement: Opioid amounts(mg). Post operative Nausea and vomiting. Timepoint: During recovery,At 4h,8h,12h,24h after surgery. Method of measurement: Categorical Scoring System for nausea. Need to postop analgesic. Timepoint: During recovery,At 4h,8h,12h,24h after surgery. Method of measurement: Analgesic amounts(mg). Zanjan University of Medical Sciences Approved 2018-03-06 Ethics committee of Zanjan University of Medical Sciences Gavazanng Blvd.,Mousavi Hosp. Zanjan Zanjan Iran (Islamic Republic of)