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IRCT20230504058083N1 IRCT 2023-10-15 Tehran University of Medical Sciences Investigating the Effect of Erector Spinae Plane Block during Posterior Cervical Spine Fusion Surgery with Lateral Mass Fixation on Postoperative Axial Pain Investigating the Effect of Erector Spinae Plane Block during Posterior Cervical Spine Fusion Surgery with Lateral Mass Fixation on Postoperative Axial Pain 2023-09-23 anticipated 60 Complete https://irct.ir/trial/71679 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the block randomization approach, the intervention and control groups will be assigned, and the randomization sequence will be performed based on the website https://www.sealedenvelope.com/simple-randomiser/v1/lists. For this purpose, 60 coded packets will be prepared, 30 of which will contain the intervention of anesthesia and the other 30 will not. The treating physician and researcher will remain unaware of the content of the packet until the last moment, and the patient's packet will be opened during the operation, and the patient will be placed in one of the two groups based on that, Blinding description: Sixty coded packets will be prepared, 30 of which will contain the intervention of anesthesia and the other 30 will not. The treating physician and researcher will remain unaware of the content of the packet until the last moment, and the patient's packet will be opened during the operation, and the patient will be placed in one of the two groups based on that. Additionally, the patient will remain unaware of which group they belong to until the end of the study. Finally, the two groups will be delivered to the statistical analyzer for analysis without the analyzer being informed of the group type for each code. 2-3 تنگی کانال گردن. Intervention 1: Intervention group: A group of 30 people receive 4 milligrams of dexamethasone and 15 cc of 0.5% bupivacaine (maximum injectable dose of bupivacaine for local injection is 175 milligrams) injected into each erector spinae plane muscle site at the end of the surgical procedure and throughout the surgical site where the skin incision is made, after washing and before closing the fascia. This injection is performed by the neurosurgeon performing the surgical procedure. Intervention 2: Control group: A group of 30 people who will not receive this drug injection, instead, they will receive 16 cc of placebo (normal saline). Yes - There is a plan to make this available What will be shared: The results and data of this study will be published honestly, accurately, and completely. Both negative and positive results, as well as budget sources, organizational affiliations, and conflicts of interest, if any, will be fully disclosed. When: The start of the data and results access period for the study will be one month after the publication of the results. To whom: The data will only be accessible to researchers employed at academic and scientific institutions and individuals who participated in this study. Conditions: The use of the data from this study is only authorized for the purpose of improving patients' health. Where to obtain: To access the data, you can contact the researcher of this project via email and submit a request to access the data. The email address is dmr.rostami@gmail.com, and the name of the researcher is Mohammad Rostami Ravari. How to obtain: The requester must clearly state their purpose for accessing the data with sufficient documentation, and if it complies with ethical and scientific principles and helps improve patient health, the data from this study will be provided to them. Comments:
public Mohammad Rostami Ravari
Shariati Hospital, Educational, Research and Treatment Center, North Kargar Street, Jalal Al Ahmad Intersection
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 dmr.rostami@gmail.com Tehran University of Medical Sciences scientific Mohammad Rostami Ravari
Shariati Hospital, Educational, Research and Treatment Center, North Kargar Street, Jalal Al Ahmad Intersection
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 dmr.rostami@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) no preoperative lower limb palsy no lower limb paralysis that would impede the patient's ability to walk no addiction to drugs (except for smoking) that would interfere with pain assessment non-pregnancy absence of a severe concurrent illness that would interfere with the investigation of the cause of pain no obstructive cardiac disease no acute neck trauma patient's full consent to participate in the study age between 18 and 65 years fusion in the C3-C7 range no sickle cell disease in the patient no sensitivity to epinephrine and anesthetics no underlying cancer 18 years 65 years Both pregnancy a significant drop in lower limb force after the surgery that would impede the patient's ability to walk after the operation acute neck trauma any accompanying illness that would interfere with the investigation of the cause of pain any concurrent surgery outside the C3-C7 range infection at the surgical site up to one week after the operation age below 18 years and above 65 years a severe diagnosed psychiatric illness or a psychiatric illness that the patient is taking medication for or has a history of taking medication to treat if the patient has a gain If the patient undergoes simultaneous neck surgery through the anterior approach addiction to drugs (except for smoking) if the reason for the surgery is a tumor M99.41 Connective tissue stenosis of neural canal of cervical region Treatment - Drugs Treatment - Drugs Intervention group: A group of 30 people receive 4 milligrams of dexamethasone and 15 cc of 0.5% bupivacaine (maximum injectable dose of bupivacaine for local injection is 175 milligrams) injected into each erector spinae plane muscle site at the end of the surgical procedure and throughout the surgical site where the skin incision is made, after washing and before closing the fascia. This injection is performed by the neurosurgeon performing the surgical procedure Control group: A group of 30 people who will not receive this drug injection, instead, they will receive 16 cc of placebo (normal saline). Postoperative pain intensity. Timepoint: 6 hours, 24 hours, 48 hours, and 1 week after surgery. Method of measurement: Numeric Rating Scale score. Amount of narcotic analgesic consumption. Timepoint: 24 hours and 48 hours after surgery. Method of measurement: The dose of injected narcotic medication is recorded in milligrams in the documents included in the file during 24 and 48 hours after the end of the surgery. Type of analgesic used. Timepoint: 24 hours and 48 hours after surgery. Method of measurement: Investigating the type of medication injected based on the documents included in the file during 24 and 48 hours after the end of the surgery. The first time the patient walks after surgery. Timepoint: Up to 48 hours after surgery. Method of measurement: The duration from the end of surgery until the patient starts walking in the ward, as observed directly and asked from the patient. The first time the patient requests pain medication. Timepoint: Up to 48 hours after surgery. Method of measurement: The time from the end of surgery until the patient requests pain medication for pain relief, recorded in hours with the help of patient questioning. Number of cervical fusion levels. Timepoint: At the end of the surgical procedure. Method of measurement: The number of cervical vertebrae that have screws inserted into them is recorded through direct observation of radiology images taken after the surgery. Tehran University of Medical Sciences Approved 2023-07-29 Research Ethics Committees of Shariati Hospital University of Tehran Married Students Dormitory, Daneshju Blvd, Tehran-Karaj Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)