]>
IRCT20130803014251N12 IRCT 2026-07-10 Tehran University of Medical Sciences Evaluation of the effect of adding dexmedetomidine to spinal anesthesia in lower limb orthopedic surgery Comparison of the efficacy of intrathecal dexmedetomidine combined with bupivacaine versus bupivacaine alone on pain, shivering, nausea, and vomiting following lower limb orthopedic surgery: a randomized double-blind clinical trial in Nasiriyah, Iraq 2026-07-16 anticipated 80 Complete https://irct.ir/trial/91491 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated in a 1:1 ratio to one of the two study groups using a computer-generated randomization sequence. Block randomization with a block size of four will be used to ensure balanced allocation between the groups. Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes (SNOSE), which will be opened only after participants have been confirmed eligible for enrollment, Blinding description: Patients, the anesthesiologist performing the spinal anesthesia, surgeons, outcome assessor, and data analyst will all be blinded to group allocation. Study drugs will be prepared by an independent anesthesiologist or nurse who is not involved in patient management, outcome assessment, or data collection. The study solutions will be prepared in identical syringes with equal volumes and labeled with coded identifiers. Outcome assessors will evaluate postoperative pain, shivering, nausea, and vomiting without knowledge of the assigned intervention. The allocation code will remain concealed until completion of data analysis unless unblinding is required for patient safety. 3 Postoperative pain following lower limb orthopedic surgery. Intervention 1: Intervention group: Participants in this group will receive spinal anesthesia with 14 mg of intrathecal hyperbaric bupivacaine combined with 5 µg of dexmedetomidine. Intervention 2: Control group: Participants in this group will receive spinal anesthesia with 14 mg of intrathecal hyperbaric bupivacaine combined with 0.5 mL of normal saline. Yes - There is a plan to make this available What will be shared: Only a part of patients' demographical data and main outcomes will be shared. When: After the publishing of the results To whom: Data will be available only for researchers working on academic and university associations. Conditions: Mention of study details and authors name Where to obtain: Dr. Morteza Nasiri: Department of Operating Room, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran How to obtain: Information will provide via the following email upon request. Mortezanasiri.or87@yahoo.com Comments:
public Dr. Morteza Nasiri
Building of Paramedical School of Tehran University of Medical Sciences, Mohammad Ebrahim Bastani Parizi Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran
Tehran Iran (Islamic Republic of) 4436114177 +98 21 8898 2907 Mnasiri@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Morteza Nasiri
Building of Paramedical School of Tehran University of Medical Sciences, Mohammad Ebrahim Bastani Parizi Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran
Tehran Iran (Islamic Republic of) 4436114177 +98 21 8898 2907 Mnasiri@sina.tums.ac.ir Tehran University of Medical Sciences Iraq Adult patients aged 18-65 years Scheduled for elective lower-limb orthopedic surgery American Society of Anesthesiologists (ASA) physical status I or II Eligible for spinal anesthesia Ability to understand and provide written informed consent 18 years 65 years Both Known hypersensitivity or contraindication to dexmedetomidine or bupivacaine Contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site, severe hypovolemia) History of chronic pain syndromes or regular opioid use Significant cardiovascular diseases (e.g., severe bradycardia, heart block, uncontrolled hypotension) Neurological or psychiatric disorders affecting pain assessment Pregnancy or lactation Treatment - Drugs Treatment - Drugs Intervention group: Participants in this group will receive spinal anesthesia with 14 mg of intrathecal hyperbaric bupivacaine combined with 5 µg of dexmedetomidine. Control group: Participants in this group will receive spinal anesthesia with 14 mg of intrathecal hyperbaric bupivacaine combined with 0.5 mL of normal saline. Postoperative pain intensity. Timepoint: During the first 24 hours after surgery (at 30 minutes and 1, 2, 4, 6, 12, and 24 hours postoperatively). Method of measurement: Visual Analog Scale (VAS). Incidence and severity of postoperative shivering. Timepoint: Immediately after spinal anesthesia, on arrival at the post-anesthesia care unit, and at 15, 30, and 60 minutes postoperatively. Method of measurement: Shivering grading scale. Incidence of postoperative nausea and vomiting (PONV). Timepoint: At 2, 6, 12, and 24 hours after surgery. Method of measurement: Direct patient questioning and clinical observation using a 3-point ordinal scale (0 = none, 1 = nausea, 2 = vomiting). Time to first rescue analgesic request. Timepoint: Continuously during the first 24 hours after surgery. Method of measurement: A structured postoperative follow-up form. Total analgesic consumption. Timepoint: During the first 24 hours after surgery. Method of measurement: A structured postoperative follow-up form. Requirement for rescue medications. Timepoint: During the first 24 hours after surgery. Method of measurement: A structured postoperative follow-up form. Tehran University of Medical Sciences Approved 2026-07-02 کمیته‌ اخلاق در پژوهش دانشکده بهداشت و پیراپزشکی دانشگاه علوم پزشکی تهران Building of Health School of Tehran University of Medical Sciences, Poursina Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)