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IRCT20230424057986N2 IRCT 2023-06-08 Iran University of Medical Sciences Investigating the effect of ultrasound- guided bilateral dual TAP block and erector spine plane block Investigating the effect of ultrasound- guided bilateral dual transverse abdominal plane block (TAP) and erector spine plane block on the postoperative quality of recovery after total abdominal hysterectomy 2023-06-27 anticipated 60 Complete https://irct.ir/trial/69902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups. The randomization tool will be a random sequence generation software called SAS. In addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 6 blocks will be formed and in each block, 3 people from first intervention group and 3 people in second intervention group will be placed. A total of 10 blocks will be considered to reach the sample size. The blocks contain numbers, odd numbers represent the first intervention group and even numbers represent the second intervention group. Their order will be determined by the software initially. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards respectively will be placed in the envelopes. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: Patients will be blinded to the type of block. Patients will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which block will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind. 3 Pain. Intervention 1: Intervention group: In patients with bilateral erector spinae plate block, at the T9 level of the lumbar vertebra, 20 cc of ropivacaine 0.2% will be used bilaterally (5 mg/ml) (manufacturer: Ropivacaine Molteni) (40 cc of ropivacaine 0.2% in total). The ultrasound probe used in this group will be a curve probe in a lateral position. Intervention 2: Intervention group: In the bilateral dual transverse abdominal plane block (TAP) group, on each side two injections, one in the umbilical alignment and the other subcostal, 15 cc of ropivacaine 0.2% (5 mg/ml) (manufacturer: Ropivacaine Molteni) (total 60 CC ropivacaine 0.2%) will be used. The ultrasound probe used in this group will be a linear probe in the supine position. 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 After completing the work and consulting with all the writers and executive agents, I will make a decision.
public Hamid Reza Feiz
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2559 hrfaiz@hotmail.com Iran University of Medical Sciences scientific Hamid Reza Feiz
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2255 9577 hrfaiz@hotmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with uterine diseases and candidates for full abdominal hysterectomy Age between 20-60 years A person with normal health A person with mild systemic disease 20 years 60 years Female Allergy to any of the drugs used in the study Addiction to alcohol, benzodiazepines and narcotics The presence of underlying diseases including kidney disease, liver disease, heart failure, arrhythmia or valvular heart disease. Coagulation disorder Contraindications for regional anesthesia Emergency patients Patients who have received analgesics in the last 24 hours G89 Pain Treatment - Other Treatment - Other Intervention group: In patients with bilateral erector spinae plate block, at the T9 level of the lumbar vertebra, 20 cc of ropivacaine 0.2% will be used bilaterally (5 mg/ml) (manufacturer: Ropivacaine Molteni) (40 cc of ropivacaine 0.2% in total). The ultrasound probe used in this group will be a curve probe in a lateral position. Intervention group: In the bilateral dual transverse abdominal plane block (TAP) group, on each side two injections, one in the umbilical alignment and the other subcostal, 15 cc of ropivacaine 0.2% (5 mg/ml) (manufacturer: Ropivacaine Molteni) (total 60 CC ropivacaine 0.2%) will be used. The ultrasound probe used in this group will be a linear probe in the supine position. Severity of patients' pain. Timepoint: 1, 2, 4, 8, 12 and 24 hours after surgery. Method of measurement: Based on visual analog scale. Iran University of Medical Sciences Approved 2023-04-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)