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IRCT20221107056427N1 IRCT 2022-11-23 Shahid Beheshti University of Medical Sciences Determining the effectiveness of erector spinae block under ultrasound guidance in analgesia after lumbar vertebral surgeries ESPB Comparison between the analgesic effects of the Erector Spinae Plane Block and direct Infiltration under the Erector Spinae muscles in degenerative lumbar vertebral surgeries 2022-05-22 anticipated 64 Complete https://irct.ir/trial/66705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A statistics consultant will perform randomization using permuted block technique. The permuted block technique randomizes patients between groups within a set of study participants, called a block. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block. The randomization sequences are delivered in sealed opaque envelopes to the anesthesiologist responsible for performing the blocks and induction of anesthesia, Blinding description: Before the start of the study and at the time of patient admission, a full explanation is given in relation to the study, and an optional informed consent form is obtained from the patients to participate in the study. The randomization sequences will be delivered in sealed opaque envelopes to the anesthesiologist responsible for performing the blocks and induction of anesthesia. The principal investigator of the project, the medical personnel, the person in charge of data collection (anesthetist assistant), and the person who analyzes the data are also not aware of the grouping of the study. N/A Degenerative Lumbar vertebral Surgeries. Intervention 1: Intervention group 1: Degenerative Lumbar vertebral Surgeries using Ultrasound-Guided Erector Spinae Plane Block: Bilateral ultrasound-guided ESPBs were performed with the patient in a prone position after induction of general anesthesia, prior to surgical incision. Blocks will be performed by experienced attending anesthesiologists, all of whom were fellowship-trained in regional anesthesia and were members of a dedicated spine anesthesia service. A C60 curved array ultrasound probe (FUJIFILM SonoSite Edge II Total) with 2-5 MHz was placed in parasagittal orientation in the midline to identify the spinous processes. The probe was translated laterally until the tips of the transverse processes were viewed. A 20-Ga 4-inch Ultraplex needle (B. Braun Medical Inc., PA, USA) was placed in-plane and advanced in a cranial-to-caudal direction until the tip was under the erector spinae plane. Depending on the patient's body mass index (BMI) 20 mL 0.25% rupivacaine was injected bilaterally at the tips of the transverse process/under visual guidance. Intervention 2: Intervention group 2: Degenerative Lumbar vertebral Surgeries using Direct Infiltration Under the Erector Spinae muscles: After the midline incision, the fascia is opened in the midline, then the muscles are dissected subperiosteally, and the muscle dissection continues from the transverse process to its lateral part. After laminectomy and screw insertion, at the end of the surgery, 20 cc of 0.25% rupivacaine solution is injected on each side on the device site. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Parisa Raji
Imam Hussein Medical, Educational, Research and Medical Center, lower than Martyr Madani Metro, Martyr Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 Raji1389@gmail.com Shahid Beheshti University of Medical Sciences scientific Parisa Raji
Imam Hussein Medical, Educational, Research and Medical Center, lower than Martyr Madani Metro, Martyr Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 raji1389@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidate for degenerative lumbar vertebral surgeries with a maximum of 4 screws in one or two adjacent vertebral levels. ASA class I and II No history of psychiatric diseases or drug and stimulant abuse No surgery or fracture in other body parts 20 years 70 years Both History of previous lumbar vertebral surgeries BMI above 30 Duration of surgery more than 4 hours Bleeding rate more than 20% of body blood volume Surgery requiring the insertion of more than 4 screws or more than two adjacent lumbar vertebrae S32.0 Fracture of lumbar vertebra Treatment - Surgery Treatment - Surgery Intervention group 1: Degenerative Lumbar vertebral Surgeries using Ultrasound-Guided Erector Spinae Plane Block: Bilateral ultrasound-guided ESPBs were performed with the patient in a prone position after induction of general anesthesia, prior to surgical incision. Blocks will be performed by experienced attending anesthesiologists, all of whom were fellowship-trained in regional anesthesia and were members of a dedicated spine anesthesia service. A C60 curved array ultrasound probe (FUJIFILM SonoSite Edge II Total) with 2-5 MHz was placed in parasagittal orientation in the midline to identify the spinous processes. The probe was translated laterally until the tips of the transverse processes were viewed. A 20-Ga 4-inch Ultraplex needle (B. Braun Medical Inc., PA, USA) was placed in-plane and advanced in a cranial-to-caudal direction until the tip was under the erector spinae plane. Depending on the patient's body mass index (BMI) 20 mL 0.25% rupivacaine was injected bilaterally at the tips of the transverse process/under visual guidance. Intervention group 2: Degenerative Lumbar vertebral Surgeries using Direct Infiltration Under the Erector Spinae muscles: After the midline incision, the fascia is opened in the midline, then the muscles are dissected subperiosteally, and the muscle dissection continues from the transverse process to its lateral part. After laminectomy and screw insertion, at the end of the surgery, 20 cc of 0.25% rupivacaine solution is injected on each side on the device site. Postoperative analgesia. Timepoint: 2, 6, 12 and 24 hours after the operation. Method of measurement: Patient file information. Morphine intake. Timepoint: 2, 6, 12 and 24 hours after the operation. Method of measurement: Patient file information. Fentanyl used during surgery. Timepoint: during the surgery. Method of measurement: observation. Shahid Beheshti University of Medical Sciences Approved 2022-05-10 ethics committee of Shahid Beheshti University of Medical Sciences Yemen Street, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)