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IRCT20120814010599N28 IRCT 2021-04-04 Iran University of Medical Sciences The effect of spinae plane block and retrolaminar block on pain control Comparison of the effect of spinae plane block and retrolaminar block,under ultrasound guidance, on pain after laparoscopic upper abdominal surgery 2021-04-22 anticipated 70 Complete https://irct.ir/trial/55156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients, using random allocation software, were randomly divided into spinae plane block and retrolaminar block groups. By entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers. If we enter the number "70" in this software, it generates 35 "Control " names and 35 "Intervention" names, which are randomly distributed and presented as a list. Patients are grouped according to this list, Blinding description: The patient and the statistical analyzer were unaware that the patient was exposed to the spinae plane block and retrolaminar block methods. Blocking was performed by an anesthesiologist in the operating room for randomly selected patients before the operation under general anesthesia. The groups are provided to the statistical analyzer in the form of codes A and B for analysis. 3 Pain. Intervention 1: Intervention group:In the group that intends to perform the Spinae plain ‌ erector block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after specifying the border of the transducer of the upper and lower lobe processes, the needle enters the skin and subcutaneous tissue In Plane and is directed to the erector muscle of the spinae plain. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected into the muscle fascia of the erector spinae plain (behind the process transducer). Intervention 2: Control group:In the group that intends to perform the ‌ retrolaminar block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after determining the lamina of the vertebra and its prickly appendage, we insert the needle 1 to 1.5 cm laterally into the prickly appendage and move towards the caudal or cranial to reach the vertebral lamina.. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected. 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 Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences scientific Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients' consent to enter the study Patients with ASA <1 & 2 Patients aged 20-60 years Patients undergoing upper abdominal laparoscopic surgery 20 years 60 years Both Emergency patients History of ropiavacaine allergy Patients who have received analgesia in a recent day Patients with a Body Mass Index>35 Patients with or underlying liver and kidney disease and coagulopathy Patients addicted to opioids G89 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group:In the group that intends to perform the Spinae plain ‌ erector block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after specifying the border of the transducer of the upper and lower lobe processes, the needle enters the skin and subcutaneous tissue In Plane and is directed to the erector muscle of the spinae plain. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected into the muscle fascia of the erector spinae plain (behind the process transducer). Control group:In the group that intends to perform the ‌ retrolaminar block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after determining the lamina of the vertebra and its prickly appendage, we insert the needle 1 to 1.5 cm laterally into the prickly appendage and move towards the caudal or cranial to reach the vertebral lamina.. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected. Pain. Timepoint: After the end of surgery and 20 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery. Method of measurement: Using Numeric Rating Scale (NRS). Patient satisfaction. Timepoint: After the end of surgery and twenty minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery. Method of measurement: poor:0,moderate:1,good:2,very good:3,excellent:4. Iran University of Medical Sciences Approved 2020-11-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)