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IRCT20200207046408N3 IRCT 2024-02-20 Yasouj University of Medical Sciences Investigating the effect of epidural analgesia with general anesthesia on pain intensity and common complications after laparoscopic cholecystectomy compared to general anesthesia A comparative study of the effect of general anesthesia , general anesthesia/ epidural analgesia on pain intensity and common complications after laparoscopic cholecystectomy 2024-04-03 anticipated 100 Complete https://irct.ir/trial/74808 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: One strategy that has not been studied so far in laparoscopic cholecystectomy is to combine general anesthesia with a less invasive regional analgesia method. Although this method has been previously investigated in surgeries such as abdominal aortic aneurysm, open surgery for pheochromocytoma, major abdominal surgery, open surgery for gastric cancer, etc., promising results on the effectiveness of this method in reducing postoperative complications, length It has shown the duration of hospitalization and its safety. But so far, no study has investigated this combined technique in laparoscopic cholecystectomy surgery in order to verify the feasibility of this method with the greatest effect and the least complications. Therefore, in this clinical trial research, the effectiveness of this new combined method will be investigated in patients undergoing laparoscopic cholecystectomy compared to general anesthesia, Randomization description: Patients who are eligible to enter the study will be randomly assigned to two groups receiving general anesthesia and general anesthesia with epidural anesthesia, Blinding description: In this study, the evaluator of pain intensity and common complications after laparoscopic cholecystectomy and the data analyzer were blinded, but the researchers were aware of the type of method used. 3 Pain intensity after laparoscopic cholecystectomy. Intervention 1: Intervention group: The intervention group patients will receive a single shot of epidural anesthesia with 0.06 mg/kg marcaine 0.05% and 0.14 ml/kg lidocaine 2% as an injection before receiving general anesthesia. Epidural injection in T12-L1, L1-L2 in the amount of 10-15 cc is performed with a No. 18 needle. Using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium will be administered under general anesthesia. Intervention 2: Control group: Patients in the control group will only receive general anesthesia using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium. 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 There is no further information
public Ali Roostapour
Shahid Gharani Blvd Shahid Jalil Hospital
Yasuj Iran (Islamic Republic of) 7591387493 +98 74 3333 7001 dr.aliroostapour@gmail.com Yasouj University of Medical Sciences scientific Reza Hosseinpour
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
Yasuj Iran (Islamic Republic of) 7591387493 +98 74 3322 1813 reza.hosseinpour@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) A patient who is a candidate for laparoscopic cholecystectomy surgery (with symptomatic gallstones without complications, with ASA grade 1 or 2) Willingness to participate in the study Age between 18 and 70 years The patient should have mental health 18 years 70 years Both Presence of concomitant systemic disease History of allergy to general anesthetics and epidural anesthesia Previous history of abdominal surgery Acute cholecystitis and acute pancreatitis Main bile duct stone cholangitis Having or suspecting gallbladder malignancy Having or suspecting heart failure and severe COPD Suffering or history of migraine pregnancy K80.10 Calculus of gallbladder with chronic cholecystitis without obstruction Treatment - Surgery Treatment - Surgery Intervention group: The intervention group patients will receive a single shot of epidural anesthesia with 0.06 mg/kg marcaine 0.05% and 0.14 ml/kg lidocaine 2% as an injection before receiving general anesthesia. Epidural injection in T12-L1, L1-L2 in the amount of 10-15 cc is performed with a No. 18 needle. Using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium will be administered under general anesthesia. Control group: Patients in the control group will only receive general anesthesia using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium. Pain intensity :Numerical rating scale of pain intensity, which is measured by asking the patient to choose a number (between 0 and 10) and based on the McGill pain intensity scale. Timepoint: Pain intensity as the main outcome in all patients in two study groups is evaluated by McGill questionnaire at the time of admission and before surgery. Then the same evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery. Method of measurement: McGill Pain Intensity Scale Questionnaire. Common complications after laparoscopic cholecystectomy :Hypotension, bradycardia, hypoxemia, headache, nausea, vomiting, right shoulder pain, abdominal discomfort related to anesthesia and pneumoperitoneum, urinary retention. Timepoint: Evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery. Method of measurement: 1. Hypotension (more than 30% decrease in baseline mean arterial pressure or systolic arterial pressure less than 90 mm Hg) 2. Bradycardia (heart rate less than 50 beats per minute) 3. Hypoxemia (SpO2 less than 90) 4. Headache or not 5. Nausea and vomiting or not 6. Right shoulder pain or not 7. Abdominal discomfort or not 8. Urinary retention or not. Yasouj University of Medical Sciences Approved 2023-07-19 Ethics committee of Yasuj University of Medical Sciences Shahid mottahari Blvd Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)