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IRCT20250929067410N1 IRCT 2026-02-08 Dr. Masih Daneshvari Educational, Research and Treatment Center comparison of analgesic effect of erector spinae plane block versus intercostal nerve blck in VATS surgery under general anesthesia without opioid EVAT(erctor vs intercostal block in VATS analgesia trial) comparison of analgesic effect of erector spinae plane block versus intercostal nerve blck in VATS surgery under general anesthesia without opioid 2025-12-26 anticipated 50 Complete https://irct.ir/trial/87705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a randomized clinical trial with parallel groups. After obtaining informed consent, eligible patients will be randomly assigned to two groups: Group A, receiving the erector spinae plate block, and Group B, receiving the intercostal block. The randomization method is based on four-blocks with an allocation ratio of 1:1. Pain intensity is assessed at intervals of 2, 6, 12, and 24 hours after surgery using the VAS scale. Patients and pain assessors are unaware of the assigned group. (Double-blind) Data will be analyzed using appropriate statistical tests including independent t-test and repeated analysis of variance, Randomization description: Each patient, after entering and confirming the inclusion criteria, is placed in one of two study groups: Group A: Erector Spina Plate Block (ESPB) Group B: Intercostal Block (ICB) The anesthesiologist is aware of the group assignment before the block is performed, but the patient and the pain assessor are unaware of the treatment group. This method prevents BIAS in the assessment (pain severity). If an eligible patient withdraws after allocation or the procedure is canceled, a replacement sample will be selected from the next random numerical block to keep the number of samples in the two groups equal, Blinding description: In this study, double-blinding is used. The patient and the pain assessor are unaware of the type of block. Only the anesthesiologist performing the block is aware of the type of intervention. The patient is under general anesthesia and remains unaware of the intervention. The pain assessor who measures the VAS score after surgery and the data analyst are not aware of the patients' treatment group. After collecting the data, they are entered into the statistical software with A-B codes and decoding is performed after the analysis is complete. This design prevents observer and patient bias in assessing the outcomes after pain and medication use. 4 Patients who are candidates for video-assisted thoracoscopic surgery under general anesthesia without narcotics. This procedure is usually performed in patients with various lung diseases such as lung masses, pleural effusions, or lung biopsies. Intervention 1: Intervention group: Intervention group: Group A: Erector spinae plate block in the lateral position after general anesthesia without narcotics and prep and drape, performed with ultrasound guidance, 20 cc of 0.25% marcaine solution is injected at the T5 level in the space between the fascia and the erector spinae muscle. The intervention is performed by an experienced anesthesiologist in this field. Number of times: once for each patient. Intervention 2: Intervention group: Intervention group: Intercostal block group, in which after general anesthesia, after positioning and before the start of surgery, 5 cc of 0.25% marcaine solution will be injected into each of the three intercostal spaces at the surgical incision site under ultrasound guidance. The total injection will be 15 cc. The intervention will be performed by an experienced anesthesiologist. The number of times is once for each patient. Yes - There is a plan to make this available What will be shared: The data from this study, including results on pain intensity, analgesic use, and possible complications of the regional block, will be provided to the research team confidentially after the final analysis is completed. The data will be coded and only the mean and standard deviation will be published in the final report When: The data will be available after the final article is completed and published. This period is estimated to be approximately 6 to 12 months after the end of data collection To whom: The data will only be available to the project implementation group, and limited and confidential access will be provided to other researchers upon written request and approval by the ethics committee Conditions: The data includes pain intensity, opioid consumption, and potential side effects of the regional block technique. The data will be coded after analysis and will be used for research and educational purposes only Where to obtain: The request will be given to the principal investigator, and coordination and authorization will be done with the supervisor and the medical ethics committee How to obtain: Applicants must submit their request in writing to the principal investigator, and after approval by the supervisor and the ethics committee, it will be submitted in an encrypted format and in accordance with the principle of confidentiality Comments: No identifying information will be included in the shareable files, and the documents will be stored on the Masih Daneshvari research server. Only the data will appear in the final article as results
public Lida Fadaizadeh / Tahera Parsa
Tehran Khayaban Shahid Bahanar (Niavaran) - Darabad - Bimaristan Ray Masih Danshuri
Tehran Iran (Islamic Republic of) 1956944413 0098021027123000 lfadaizadeh@gmail.com Shahid Beheshti University of Medical Sciences scientific lida fadaizadeh/tahereh parsa
Tehran Khayaban Shahid Bahanar (Niavaran) - Darabad - Bimaristan Ray Masih Danshuri
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3000 lfadaizadeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1- age between 18 and 70 years 2- scheduled for video - assisted thoracoscopic surgery under general anesthesia with out opioid administration.3- asa physical status 1-3 4- ability to provide witten informed consent 5- no known allergy to syudy drug (local anesthesia such as bupivacaine or ropivacaine) 18 years 70 years Both 1- Unwillingness to participate in the study or withdrawal at any stage 2- History of major thoracic surgery or anatomical changes that prevent proper block implementation 3- Infection at the block injection site 4- Severe cardiac, pulmonary, or renal disease that increases the risk of anesthesia 5- Coagulation disorders or use of active anticoagulant drugs 6- Pregnancy or breastfeeding 7- Inability to assess pain j90 c34.9 Lung mass, pleural effusion, or lung biopsy condidates undergoing vats surgery Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Group A: Erector spinae plate block in the lateral position after general anesthesia without narcotics and prep and drape, performed with ultrasound guidance, 20 cc of 0.25% marcaine solution is injected at the T5 level in the space between the fascia and the erector spinae muscle. The intervention is performed by an experienced anesthesiologist in this field. Number of times: once for each patient Intervention group: Intervention group: Intercostal block group, in which after general anesthesia, after positioning and before the start of surgery, 5 cc of 0.25% marcaine solution will be injected into each of the three intercostal spaces at the surgical incision site under ultrasound guidance. The total injection will be 15 cc. The intervention will be performed by an experienced anesthesiologist. The number of times is once for each patient Postoperative pain intensity at 2, 6, 12, and 24 hours after surgery based on the visual analog scale (VAS). Timepoint: At 2, 6, 12, 24 hours after surgery. Method of measurement: Using a visual analogue scale (VAS) of pain by a pain assessor who is unaware of the patient grouping. Changes in vital signs (blood pressure, heart rate, oxygen saturation) in the hours after surgery. Timepoint: Measurement by pain assessor at 2, 6, 12, and 24 hours after surgery. Method of measurement: % -mmhg-bpm. Possible complications with the block, such as hematoma, pneumothorax, and hypotension. Timepoint: Clinical assessment and recording during the 24 hours after surgery. Method of measurement: Incidence percentage. Amount of pain medication used within 24 hours after surgery. Timepoint: Record the total amount of painkillers prescribed, such as diclofenac, acetaminophen, or other narcotics, in the patient's record within 24 hours after surgery. Method of measurement: Units based on milligrams, for example 2 mg of morphine intravenously three hours after surgery. Dr. Masih Daneshvari Educational, Research and Treatment Center Approved 2025-10-12 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran, Shahid Bahonar Street (Niavaran), Darabad Tehran Tehran Iran (Islamic Republic of)