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IRCT20230520058233N1 IRCT 2023-07-11 Oroumia University of Medical Sciences The effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries Comparison of the effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries 2023-08-23 anticipated 60 Complete https://irct.ir/trial/71096 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to two groups using the Block Randomization method based on generated-numbers by the Random Allocation computer software. In this software, the number of groups and the total sample size will be entered first, and then the Block randomization method will be implemented in the block section. Therefore, based on the total sample size (60 patients), 15 blocks of four will be used, Blinding description: The study will be conducted as a single-blind clinical trial. The patients will be blind of their allocation in one of intervention groups. So, the table of computer-generated numbers will be given to the physician. The physician will enter the patients into groups according to the order of numbers. 3 Analgesia after lumbar spine surgeries. Intervention 1: Intervention group: For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closure following laminectomy. Intervention 2: Intervention group: For patients in the second group, 70 mg of 0.25% bupivacaine will be injected intramuscularly paravertebrally 30 minutes before wound closure. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Peyman Gholipour
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3345 7286 gholipour.p@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Peyman Gholipour
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3345 7286 gholipour.p@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients undergoing lumbar spine surgery with general anesthesia Age between 18 and 65 years old Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II) 18 years 65 years Both Body mass index above 30 kg/m2 History of seizure disorder Severe systemic disease Coagulation disorders Drug abusers Treatment - Drugs Treatment - Drugs Intervention group: For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closure following laminectomy. Intervention group: For patients in the second group, 70 mg of 0.25% bupivacaine will be injected intramuscularly paravertebrally 30 minutes before wound closure. Pain severity. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Visual analogue scale (VAS). Time of first request for analgesic medication. Timepoint: In 24 hours after the surgery. Method of measurement: Time of request by the patient. Dosage of morphine analgesic medication. Timepoint: In 24 hours after the surgery. Method of measurement: Miligeram. Mean arterial blood pressure. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring by device. Heart rate. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring by device. Oroumia University of Medical Sciences Approved 2023-05-14 Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences. Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)