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IRCT20200502047277N6 IRCT 2021-09-29 Shahid Beheshti University of Medical Sciences Steroids in posterior spinal fusion Comparing the effects of local intraoperative epidural use of triamcinolone-soaked Gelfoam with normal saline -soaked Gelfoam on postoperative outcomes in patients undergoing posterolateral lumbar spinal fusion surgery 2021-10-01 anticipated 100 Complete https://irct.ir/trial/58944 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (1:1) with a block size of 4 will be performed using the SPSS 24, and sealed opaque envelopes will be used for allocation concealment. In SPSS, after dividing the study population into blocks, random numbers between 0 and 1 will be generated for each patient using RV.UNIFORM(0,1) and after determining the rank within each block, the two lower ranks will be assigned to treatment group 1, and the two upper ranks will be assigned to treatment group 2. Except for the surgeon performing the study intervention, patients, principal investigator, outcome assessors, and data analyzers will remain blind to the randomization and allocation, Blinding description: Patients, the principal investigator, outcome assessors, and data analyzers will be blind to the study intervention. For allocation concealment, sealed opaque envelopes will be used (treatment 1 or 2). Due mainly to the nature of the study intervention, the surgeon will not be blind to the allocation process and intervention received by the patients and will perform the study intervention or placebo based on the study group (treatment 1 or 2). The surgeon will remain out of the process of data collection, outcome assessment, or analysis. Postoperatively, all patients, outcome assessors and analyzers, and the principal investigator will only know the study group (treatment 1 or 2) and will remain blind to the intervention performed in each group throughout the study. 3 Fusion of spine, lumbar region. Intervention 1: Intervention group: A Gelfoam soaked in 1 ml of triamcinolone acetonide (40 mg/ml, TriamHEXAL; HEXAL AG, Holzkirchen, Germany) for five minutes, will be placed placed over the nerve roots. After the placement of Gelfoam, the surgical closure will be performed. Intervention 2: Control group: Similar to the treatment group, a Gelfoam soaked in 1 ml of normal saline for five minutes, will be placed over the nerve roots. After the placement of Gelfoam, the surgical closure will be performed. 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 There is no further information
public Roozbeh Tavanaei
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2270 1022 rtavanaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Saeed Oraee yazdani
Tajrish
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 saeed_o_yazdani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age greater than 18 years Degenerative indications for elective posterior instrumented lumbar spinal fusion surgery Written informed consent 18 years no limit Both Non-degenerative pathologies (e.g., tumor, trauma, deformity, or infection) Hypersensitivity reaction to the study drug American Society of Anesthesiologists (ASA) physical status> 2 Concurrent psychiatric disorder M43.26 Fusion of spine, lumbar region Treatment - Drugs Placebo Intervention group: A Gelfoam soaked in 1 ml of triamcinolone acetonide (40 mg/ml, TriamHEXAL; HEXAL AG, Holzkirchen, Germany) for five minutes, will be placed placed over the nerve roots. After the placement of Gelfoam, the surgical closure will be performed. Control group: Similar to the treatment group, a Gelfoam soaked in 1 ml of normal saline for five minutes, will be placed over the nerve roots. After the placement of Gelfoam, the surgical closure will be performed. 10-point visual analog scale (VAS) for postoperative pain. Timepoint: baseline, 2, 4, 6, 12, 24, and 48 h with 1, 4, and 12 weeks postoperatively. Method of measurement: Visual analog scale. Cumulative postoperative 24 h morphine consumption. Timepoint: 24 h postoperatively. Method of measurement: Patient-controlled analgesia device. Oswestry disability index (ODI). Timepoint: 1 and 4 weeks postoperatively. Method of measurement: Questionnaire. Length of stay. Timepoint: Until discharge. Method of measurement: follow-up. Postoperative nausea and vomiting. Timepoint: Every 4 h for 24 h postoperatively. Method of measurement: follow-up and observation. Postoperative complications. Timepoint: Once a week for 12 weeks after the surgery. Method of measurement: follow-up and observation. Shahid Beheshti University of Medical Sciences Approved 2020-11-22 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)