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IRCT20230717058820N1 IRCT 2023-11-01 Kerman University of Medical Sciences Intrathecal Morphine or Fentanyl for Spine Surgery Comparison of Intrathecal Morphine and Fentanyl in Postoperative Pain Management of Spine Surgeries 2023-11-01 anticipated 80 Complete https://irct.ir/trial/71377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization will be used utilizing a computer-generated randomization sequence to assign participants into two groups (morphine or fentanyl). Accordingly, by using random number generator, a random sequence is created including numbers 1 and 2 (so that there are equal numbers in each group as the calculated sample size) and based on that, every patient who meets the criteria of the study will be assigned to one of two study groups, Blinding description: Both participants and the research team who were in charge of the assessment of the outcomes will be blinded to the treatment assignment. Due to the fact that drug injection is performed during surgery and under anesthesia, patients are automatically blinded to the type of treatment. The person who is responsible for evaluating the outcomes will also be blinded regarding the type of treatment, so that the outcome assessor will not be informed about the type of treatment (morphine/fentanyl). The outcome assessor is a neurosurgery resident who measures the outcomes of the study. 3 Spinal Diseases. Intervention 1: Intervention group: Intrathecal morphine (0.2 mg) which is injected in the L3-L4 or L4-L5 intervertebral space in a single dose at the end of the surgery in the prone position using a 23 needle gauge. Intervention 2: Intervention group: Intrathecal fentanyl (25 µg) which is injected in the L3-L4 or L4-L5 intervertebral space in a single dose at the end of the surgery in the prone position using a 23 needle gauge. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Ehsan Parsa
Valiasr crossroad, Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 76137 47181 +98 34 3223 5011 ehsanparsa1991@gmail.com Kerman University of Medical Sciences scientific Mohammad Ehsan Parsa
Valiasr crossroad, Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 76137 47181 +98 34 3223 5011 ehsanparsa1991@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 85 American Society of Anesthesia (ASA) classification I or II Candidates for surgeries of spine Informed consent to enter the study 18 years 85 years Both Pregnancy or breastfeeding at the time of enrollment History of allergy to local anesthetic agents History of cardiac or renal failure Opioid use disorder Uncontrolled blood pressure Body mass index above 40 kg/m2 Preoperative heart rate less than 50 beats/min Spinal cord injuries that could interfere with the pain assessment Incidental intraoperative durotomy G95.9 Disease of spinal cord, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intrathecal morphine (0.2 mg) which is injected in the L3-L4 or L4-L5 intervertebral space in a single dose at the end of the surgery in the prone position using a 23 needle gauge. Intervention group: Intrathecal fentanyl (25 µg) which is injected in the L3-L4 or L4-L5 intervertebral space in a single dose at the end of the surgery in the prone position using a 23 needle gauge. Postoperative pain intensity. Timepoint: 4, 6, 12, 18 hours post-operation. Method of measurement: Visual Analogue Scale. Time interval from the surgical procedure until the patient required supplementary analgesics. Timepoint: From the operation till maximum 18 hours. Method of measurement: Timer. Side effects (Postoperative nausea/vomiting, pruritus, dyspnea, respiratory depression). Timepoint: From the operation till maximum 18 hours. Method of measurement: Subjective assessment. Kerman University of Medical Sciences Approved 2023-01-03 Ethics Committee of Kerman University of Medical Sciences Jahad Street Kerman Kerman Iran (Islamic Republic of)