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IRCT20210815052193N1 IRCT 2022-05-02 Tehran University of Medical Sciences Effect of Methyl prednisolone, Morphine sulphate and Bupivacaine on post operation back pain The comparison of the effects of intaoperative injection of Methyl prednisolone,Morphine sulphate and Bupivacaine on patients' post-operative pain after lumbar discectomy 2022-05-22 anticipated 150 Complete https://irct.ir/trial/62784 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, the simple randomization method will be used individually for each patient. we will put enough cards (as patients) named as groups numbers in an envelope. Each patient who is eligible to enter to the study will be assigned to a group by chance as each card comes out of the envelope, Blinding description: In this study, patients participating in the study will be blind about their group and the type of injected drugs. Due to the fact that one of the drugs has a special color, so it is not possible to keep the physician and researcher blind. 3 Low back pain after lumbar discectomy. Intervention 1: Intervention group: Patients who use 40 mg of methylprednisolone on their epidural space. Intervention 2: Intervention group: Patients who use 5 mg of morphine sulfate (soakd to a gelfoam) on their epidural space. Intervention 3: Intervention group: Patients who receive 20 cc of bupivacaine as infiltrated into the paraspinal muscles and around the woun. Intervention 4: Intervention group: Patients who use 40 mg of methylprednisolone and 5 mg of morphine sulfate on the epidural space during surgery, and 20 cc bupivacaine are infiltrated into their paraspinal muscles and around the wound. Intervention 5: Control group: The control group in which gelfoam impregnated with normal saline is used in the epidural space and 20 cc of normal saline is infiltrated in the paraspinal muscles and around the wound. Yes - There is a plan to make this available What will be shared: Data related to outcomes of the intervention would be shared When: 1 year after publication of resuls To whom: Valid researchers Conditions: for research purposes Where to obtain: Mohamad Namvar How to obtain: Email sending and assessing the request in ethics committee Comments:
public Mohamad Namvar
Baqer khan
Tehran Iran (Islamic Republic of) 5651694774 +98 21 6119 2634 mohamad.namvar@gmail.com Tehran University of Medical Sciences scientific Mohamad Namvar
Baqer khan
Tehran Iran (Islamic Republic of) 5651694774 +98 21 6119 2634 mohamad.namvar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients based on MRI diagnosed as intervertebral disc herniation (L4-L5 or L5-S1) who are candidates for open discectomy according to attending physician opinion 18 years 65 years Both patients aged below 18 and more than 65 Addiction to opioids known allergy to corticosteroids, morphins and bupivacaine History of spine surgery M54.5 Low back pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients who use 40 mg of methylprednisolone on their epidural space Intervention group: Patients who use 5 mg of morphine sulfate (soakd to a gelfoam) on their epidural space Intervention group: Patients who receive 20 cc of bupivacaine as infiltrated into the paraspinal muscles and around the woun Intervention group: Patients who use 40 mg of methylprednisolone and 5 mg of morphine sulfate on the epidural space during surgery, and 20 cc bupivacaine are infiltrated into their paraspinal muscles and around the wound Control group: The control group in which gelfoam impregnated with normal saline is used in the epidural space and 20 cc of normal saline is infiltrated in the paraspinal muscles and around the wound. Severity of back pain after lumbar discectomy. Timepoint: At 3, 6, 12, 24 hours. Method of measurement: visual analogue score questionnaire. Number of needed intravenous opioids. Timepoint: 24 hours after surgery. Method of measurement: Number of injected times by nurse. Tehran University of Medical Sciences Approved 2021-10-09 Ethics committee of the Tehran University of Medical Sciences Imam Khomeini Hospital, Baqer khan st Tehran Tehran Iran (Islamic Republic of)