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IRCT20241116063729N1 IRCT 2025-04-09 Mashhad University of Medical Sciences Intrathecal administration of combination of dexmedetomidine and bupivacaine for postoperative pain relief in elective caesarean section patients Safety and Efficacy of Intrathecal Combination of Dexmedetomidine and Bupivacaine for Postoperative Pain Management in Cesarean Section Patients: Randomized Controlled Trial 2025-04-21 anticipated 200 Complete https://irct.ir/trial/80179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists Block randomization will be performed in 4 and 8 block sizes: Block sizes: 4,8 Actual list length: 204 block identifier, block size, sequence within block, treatment, Blinding description: For concealment, opaque, sealed, sequentially numbered envelopes are used so that the assigned group is not known before the individual is assigned. In this study, the patient and the analyst are blind to the assignment, but the anesthesiologist in charge is fully aware of the assignment so that he or she can deal with and treat any complications that may arise. Considering that the patient is positioned lying on their side, and the medication is administered from the back in the intervertebral space of the lower back, which is out of the patient's view, and also due to the patient's lack of precise knowledge about the content of the syringe, the patient will remain blind to their allocation to any of the study groups. N/A pain. Intervention 1: Intervention group A : Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.2 cc (equivalent to 5 micrograms) + 0.2 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Intervention 2: Intervention group B: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.3cc (equivalent to 5 micrograms) + 0.1cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Intervention 3: Intervention group C: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.4cc (equivalent to 5 micrograms) + Without 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Intervention 4: Control group D:Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Without Dexmedetomidine + 0.4 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. No - There is not a plan to make this available Justification or reason for not sharing IPD is Sharing the data will be possible upon reasonable request from the project manager
public Mohammad Alipour
Ahmad-Abad Street
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3840 0001 alipourm@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Alipour
Ahmad-Abad Street
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3840 0001 alipourm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Candidate for elective cesarean section Spinal anesthesia as the method of choice for cesarean section Written consent from the patient to participate in the study No history of allergy to the medications used in the study Lack of blood, infectious, or neurological disorders that may cause problems with spinal anesthesia 18 years 45 years Female Need for changing the anesthesia method during surgery Allergic reaction/hypersensitivity to the medications used in this study R52 Pain, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group A : Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.2 cc (equivalent to 5 micrograms) + 0.2 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Intervention group B: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.3cc (equivalent to 5 micrograms) + 0.1cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Intervention group C: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.4cc (equivalent to 5 micrograms) + Without 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Control group D:Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Without Dexmedetomidine + 0.4 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae. Pain Intensity. Timepoint: at 2,4,6,12, and 24 hours after operation. Method of measurement: The patient is asked to rate her pain based on the VAS scale (0 to 10). Analgesic Consumption. Timepoint: As per complain from pain or at defined time points. Method of measurement: The cumulative analgesic consumption during the 24 h after surgery will be recorded. Possible adverse effects of the intervention. Timepoint: During the 24 h after surgery. Method of measurement: Adverse effects including the hypotension, bradycardia, gastrointestinal symptoms, allergic reactions, and injection site reaction will be recorded. Mashhad University of Medical Sciences Approved 2024-10-13 Research Ethics committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad Ebnesina Ave., Daneshgah Blvd., Mashhad city Mashhad Razavi Khorasan Iran (Islamic Republic of)