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IRCT20100127003213N6 IRCT 2019-07-07 Shiraz University of Medical Sciences The effect of bilateral lumbar erector spine plane block on postoperative pain of lumbar laminectomy operation The effect of bilateral lumbar erector spine plane block on postoperative pain of lumbar laminectomy operation 2019-07-21 anticipated 50 Complete https://irct.ir/trial/39605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using random numbers or the Randomizer.org site, patients fall into one of two B or C groups. The name of each patient's group will be readily available in closed envelopes by a staff member who already has access to the randomized list of patients, Blinding description: Participants, such as anesthetist, anesthetist technician, surgeon, and those responsible for collecting data, are unaware of the patient's study group. 2-3 lumbar laminectomy operation. Intervention 1: Intervention group: Patients in the intervention group sit in the sitting position and undergo transient ultrasonography of the lumbar vertebrae and with spinal needle 22, 20 cc of bupivacaine 0.25% is injected on each side of the lumbar spine, and then patients will be under general anesthesia. Intervention 2: Control group: In the control group, 20 cc of bupivacaine 0.25% will injected on each side of the lumbar vertebra under general anesthesia. 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 It is against our policies.
public Seeyed Amir Reza Akhlagh
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 amirakhlagh@hotmail.com Shiraz University of Medical Sciences scientific Arash Farbood
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 1564471948 +98 36474270 arashfarbood@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients undergoing lumbar laminectomy surgery. age range of 18-65. (ASA = 1 or 2). patients who are mentally capable of cooperating with the study and answering questions. 18 years 65 years Both Uncontrolled seizures Depression Local infection Rupture and repair of dura Severe coagulation disorder Substance abuse and dependence sensitivity to any of the drugs used in the study Patients who need mechanical ventilation post opeartively Patients with psychotic somatic pain M43.26 Fusion of spine, lumbar region Prevention N/A Intervention group: Patients in the intervention group sit in the sitting position and undergo transient ultrasonography of the lumbar vertebrae and with spinal needle 22, 20 cc of bupivacaine 0.25% is injected on each side of the lumbar spine, and then patients will be under general anesthesia. Control group: In the control group, 20 cc of bupivacaine 0.25% will injected on each side of the lumbar vertebra under general anesthesia. Pain Severity. Timepoint: Every 15 minutes (at intervals of 15-30-45-60 minutes) in the operating room and then in the ward every one hour at the first 6 hours , every 2 hours at the second 6 hours and every 4 hours after the next 12 hours. Method of measurement: Numerical Rating Scale. Patients Satisfaction. Timepoint: 24 hours after surgery. Method of measurement: Likert Scale. Shiraz University of Medical Sciences Approved 2019-01-31 Ethics committee of Shiraz University of Medical Sciences Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)