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IRCT20201026049147N1 IRCT 2020-12-09 Mazandaran University of Medical Sciences Effect of buprenorphine on pain intensity after surgery Evaluating the effect of preoperative sublingual buprenorphine on pain intensity after lumbar disc surgery 2018-03-21 anticipated 78 Complete https://irct.ir/trial/51857 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into intervention and placebo groups by blocking method. Random numbers were generated for blocks with random allocation software. Samples were assigned in 11 blocks of 7 based on randomly generated numbers, Blinding description: The blinding of the study is done in such a way that the drug is given to the patient in advance by the ward nurse, which is prepared based on block randomization and the patient group. Patient and the researcher unaware about the grouping. 3 Post-operative pain. Intervention 1: Intervention group: Received a single sublingual 2 mg Bupernorphine tablet (manufactured by Jalinous pharmaceutical company) one hour before surgery. Intervention 2: Control group: Received placebo sublingual one hour before surgery. 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 Due to the confidentiality of information
public Hojat Deilami
Imam khomeini hospital, Amir Mazandari street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3331 1111 hojatdeilami@gmail.com Mazandaran University of Medical Sciences scientific Farshad Hasanzadeh Kiabi
Imam khomeini hospital, Amir Mazandari street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3331 1111 Fhasanzadehk@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patient candidate for elective discectomy with 1 or 2 lumbar discs With ASA class I and II Age range 35-70 Conscious consent to participate in the study Hypersensitivity to buprenorphine Confirmation of diagnosis by physical examination, CT scan and MRI Patient's willingness to participate in the study and obtaining informed consent 35 years 70 years Both Patient's unwillingness at any time to continue the study Incidence of any uncommon side effects during surgery. Alcohol or drug abuse Opioids use 24 hours prior to intervention Involvement of more than two lumbar disc G89.22 Chronic post-thoracotomy pain Treatment - Drugs Treatment - Drugs Intervention group: Received a single sublingual 2 mg Bupernorphine tablet (manufactured by Jalinous pharmaceutical company) one hour before surgery. Control group: Received placebo sublingual one hour before surgery. Opium usage. Timepoint: 0, 2, 4, 6, 12, 24 hours after surgery. Method of measurement: Checklist. Pain severity. Timepoint: 0, 2, 4, 6, 12, 24 hours after surery. Method of measurement: Visual analogue scale. Mazandaran University of Medical Sciences Approved 2018-06-27 Ethics committee of Mazandaran University of Medical Sciences Amir Mazandarani St. Sari Mazandaran Iran (Islamic Republic of)