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IRCT20190413043260N1 IRCT 2019-04-25 Arak University of Medical Sciences Effect of Oxiplex Gel in lumbar disk herniation surgery Evaluation the effectiveness of Oxiplex Gel for reduction of pain and associated symptoms following single level lumbar discectomy 2018-03-21 anticipated 60 Complete https://irct.ir/trial/38867 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: <Randomiziation formed with statistical method , site-specific and computer-generated in blocks of 4 and 2 , based on each number, boxes with specific identified number containing Oxiplex Gel or Placebo dedicated, Blinding description: All patient participating , the surgeon and outcome assessment are blind in this study. Boxes in similar size and form with specific identified number which include Oxyplex Gel or the similar placebo will be delivered to the surgeon at the termination of surgery and the surgeon have no information about the type of syringe`s contents when he uses the syringe. N/A Lumbar disc herniation. Intervention 1: Intervention group : at the end of open lumbar discectomy surgery and before closure , 3 cc of Oxiplex Gel will be injected to surgery site on dura and nerve roots. Oxiplex Gel (carboxymethylcellulose, polyethylene oxide, and calcium) made in Fzio Med Inc is a clear , absorbable and anti fibrosis agent that it`s safety for human being is approved. Intervention 2: Control group: at the end of open lumbar discectomy surgery and before closure , 3 cc of placebo will be injected to surgery site on dura and nerve roots. Yes - There is a plan to make this available What will be shared: All data after unrecognizaton the patients can be shared When: beginning of accessibility is six month after publication To whom: researchers working at university Conditions: for clinical use Where to obtain: My email address ( keyhan _poorali @yahoo.com ) How to obtain: About one week to one month after request data file will be send Comments:
public Keyhan Poorali
No 7 ,Faridi Alley, Rajae Ave
Arak Iran (Islamic Republic of) 3813957517 +98 86 3221 5657 keyhan_poorali@yahoo.com Arak University of Medical Sciences scientific Keyhan Poorali
No 7 , Faridi Alley , Rajaei Ave
Arak Iran (Islamic Republic of) 3813957517 +98 86 3221 5657 keyhan_poorali@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patient with single level lumbar disk herniation Patients who are candidate for discectomy surgery for treatment based on physical examination and radiologic evaluation 18 years 70 years Both Patient with multilevel lumbar disk herniation History of previous lumbar surgery M51.1 Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy Treatment - Other Treatment - Other Intervention group : at the end of open lumbar discectomy surgery and before closure , 3 cc of Oxiplex Gel will be injected to surgery site on dura and nerve roots. Oxiplex Gel (carboxymethylcellulose, polyethylene oxide, and calcium) made in Fzio Med Inc is a clear , absorbable and anti fibrosis agent that it`s safety for human being is approved. Control group: at the end of open lumbar discectomy surgery and before closure , 3 cc of placebo will be injected to surgery site on dura and nerve roots. Disability index. Timepoint: Before surgery , 1 month , 3 month, 6 month after surgery. Method of measurement: Oswestry Disability Index (ODI) questionnaire. Arak University of Medical Sciences Approved 2018-06-17 Ethics comittee of Arak University of Medical Sciences No. 7, Faridi Alley ,Rajaei Ave Arak Markazi Iran (Islamic Republic of)