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IRCT20200214046488N1 IRCT 2020-03-16 Zanjan University of Medical Sciences Topical effect of Bupivacaine, Bupivacaine plus Epinephrine and Bupivacaine-Dexamethasone on pain relief after lumbar disc surgery Comparison of topical effects of Bupivacaine, Epiphirin Bupivacaine and Bupivacaine-Dexamethasone on pain relief after lumbar disc surgery 2019-09-16 anticipated 40 Complete https://irct.ir/trial/45887 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization was performed using the shuffling card method. In addition, measures have been taken by patients who were not directly involved in the study regarding patient registration, patient assignment, and patient management, Blinding description: This study is a double-blind clinical trial in which patients do not know the type of drug due to general anesthesia. Also, the team of researchers is not involved in the treatment process. 2-3 Lumbar Discopathy. Intervention 1: Intervention group1: In this group, 20 mg Bupivacaine is added to the surgical incision site after surgery and before surgery, and then the incision site is closed. Intervention 2: Intervention group2: In this group, 20 mg Bupivacaine and 50 µg epinephrine were added to the surgical incision site before surgery and the incision site was closed. Intervention 3: Intervention group3: In this group, 20 mg Bupivacaine and 4 mg Dexamethasone will be added to the surgical incision site before surgery, and then the incision site will be closed. Intervention 4: Control group: In this group there is no intervention and no drugs are added. Yes - There is a plan to make this available What will be shared: All questionnaires are fully shareable after ensuring that they are unrecognizable, including deleting the file name and number. When: Start access period 6 months after publishing results for 6 months To whom: The data will be available to all researchers at universities Conditions: It is necessary for researchers to access the data to submit research proposals to academic institutions Where to obtain: Contact Dr. Mona Rastegar and email m0na_rastegar@yahoo.com for data. How to obtain: The data becomes available to the researcher about 2 weeks after submitting the approved proposal to the academic institution. Comments:
public Mona Rastgar
Gavazang road
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 M0na_rastegar@yahoo.com Zanjan University of Medical Sciences scientific Mona Rastgar
Gavazang road
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 M0na_rastegar@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Ages 20 and under 60 years Absence of uncontrolled underlying disease (ASA Class 1 and 2) No history of drug abuse Patients who need up to 4 levels of the spine need surgery 20 years 60 years Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: In this group, 20 mg Bupivacaine is added to the surgical incision site after surgery and before surgery, and then the incision site is closed. Intervention group2: In this group, 20 mg Bupivacaine and 50 µg epinephrine were added to the surgical incision site before surgery and the incision site was closed. Intervention group3: In this group, 20 mg Bupivacaine and 4 mg Dexamethasone will be added to the surgical incision site before surgery, and then the incision site will be closed. Control group: In this group there is no intervention and no drugs are added Patient pain score based on VAS. Timepoint: 3, 6, 12 and 24 hours after patient recovery. Method of measurement: Based on VAS (Visual Analog Scale). Zanjan University of Medical Sciences Approved 2019-09-14 Ethics committee of Zanjan University of Medical Sciences Ayatollah Musavi Hospital, Gavazang Road Zanjan Zanjan Iran (Islamic Republic of)