]>
IRCT20230518058225N1 IRCT 2023-06-23 Iran University of Medical Sciences Effect of ultrasound guided erector spinalis plane block and parascapular sub ilio-costalis plane block on the pain control Comparison effect of ultrasound guided erector spinalis plane block and parascapular sub ilio-costalis plane block on the pain control after video associated thoracic surgery 2023-07-06 anticipated 40 Complete https://irct.ir/trial/70546 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, 4 blocks will be formed and in each block, 2 people from intervention group and 2 people in control 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 intervention group and even numbers represent the control 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 1: In this group, before the start of surgery, patients under erector spina plain block are placed under ultrasound guidance with a linear prop on the surgical side. After monitoring, the patients are placed in a sitting position, and on the surgical side, after the probe and drape, the linear ultrasound probe is placed longitudinally in alignment with the T4 vertebra (transverse process) and after defining the transverse processes edge of the upper and lower vertebral, the needle enters the skin and subcutaneous tissue and is directed to the erector spinae plane muscle. A volume of 20 cc of ropivacaine 0.5% (Manufacturing company: Varian Pharmed) is injected into the fascia of the erector spinae plain muscle (behind the transverse process). Intervention 2: Intervention group 2: In the second group, before the start of surgery, patients are placed under sub ilio-costalis block with the help of ultrasound guidance with a linear prop on the surgical side. After monitoring, the patients are placed in a sitting position and the hands are placed by the patient's side, and on the surgical side, after probe and drape, a linear ultrasound probe is placed longitudinally and aligned with the T4 vertebra in the parasagittal axis, and after defining the inner edge of the scapula and the edge of its spinous process, we insert the needle 2 cm medial to the spinous process of the scapula and proceed towards the caudal or cranial side to reach the ili-ocostal-intercostal fascia in the vicinity of the fourth rib and after ensuring the location of the needle with 2 cc Saline, a volume of 20 cc of ropivacaine 0.5% (Manufacturing company: Varian Pharmed) is injected in that place. 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 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
تهران Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients undergoing video associated thoracic surgery A person with normal health A person with mild systemic disease Age between 20-60 years 20 years 60 years Both Emergency patients with organic problems History of sensitivity to ropivacaine Patients who have received analgesics in the last day Patients with body mass index less than 35 Patients with underlying liver and kidney disease and coagulopathy or a history thereof Patients who are addicted to opioids. G89 Pain, not elsewhere classified Treatment - Other Treatment - Other Intervention group 1: In this group, before the start of surgery, patients under erector spina plain block are placed under ultrasound guidance with a linear prop on the surgical side. After monitoring, the patients are placed in a sitting position, and on the surgical side, after the probe and drape, the linear ultrasound probe is placed longitudinally in alignment with the T4 vertebra (transverse process) and after defining the transverse processes edge of the upper and lower vertebral, the needle enters the skin and subcutaneous tissue and is directed to the erector spinae plane muscle. A volume of 20 cc of ropivacaine 0.5% (Manufacturing company: Varian Pharmed) is injected into the fascia of the erector spinae plain muscle (behind the transverse process). Intervention group 2: In the second group, before the start of surgery, patients are placed under sub ilio-costalis block with the help of ultrasound guidance with a linear prop on the surgical side. After monitoring, the patients are placed in a sitting position and the hands are placed by the patient's side, and on the surgical side, after probe and drape, a linear ultrasound probe is placed longitudinally and aligned with the T4 vertebra in the parasagittal axis, and after defining the inner edge of the scapula and the edge of its spinous process, we insert the needle 2 cm medial to the spinous process of the scapula and proceed towards the caudal or cranial side to reach the ili-ocostal-intercostal fascia in the vicinity of the fourth rib and after ensuring the location of the needle with 2 cc Saline, a volume of 20 cc of ropivacaine 0.5% (Manufacturing company: Varian Pharmed) is injected in that place. Severity of patients' pain. Timepoint: 0, 2, 6, 12 and 24 hours after surgery. Method of measurement: Numerical pain rating scale. Iran University of Medical Sciences Approved 2023-02-08 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)