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IRCT20170515033986N4 IRCT 2022-03-24 Oroumia University of Medical Sciences The effect of dexmedetomidine on postoperative analgesia in patients undergoing femoral fracture surgery Investigating the effect of using dexmedetomidine in fascia iliaca block on postoperative analgesia in patients undergoing femoral fractures surgery 2022-04-05 anticipated 80 Complete https://irct.ir/trial/61131 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using permuted block randomization based on generated numbers by random allocation software (20 blocks of 4 letters), Blinding description: Current study is a double blind study. The patient and the person who will be assessed the outcomes (anesthesia assistant) will be blind about the intervention or control groups. therefore, the drugs will be drawn and coded inside the syringes by an anesthesiologist, and the block will be performed by an anesthesia assistant that who is unaware of the contents of the syringes. 3 Analgesia in femoral fractures. Intervention 1: Intervention group: Iliaca fascia block will beperformed using 20 cc of bupivacaine 0.25% with 0.5 cc of dexmedetomidine 50μg. Intervention 2: Control group: Iliaca fascia block will be performed using only 20 cc of bupivacaine 0.25%. Yes - There is a plan to make this available What will be shared: The results of the study will be available as an article. Other files, including data and the consent form, can also be accessed through email address of corresponding author. When: after published article To whom: researchers Conditions: The data can be provided for use in meta-analysis, network meta-analysis or any secondary analysis with research purposes. Where to obtain: corresponding author (Nazli Karami). Data will be available by sending an email to karami.n@umsu.ac.ir How to obtain: By email address to karami.n@umsu.ac.ir Comments:
public Dr. Nazli Karami
Imam Khomeini hospital, Ershad street, Modarres blvd., Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 karami.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Nazli Karami
Imam khomeini hospital, Ershad street, Modarres Blvd., Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 karami.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with femoral fracture surgery under spinal anesthesia Patients with ASA I and ASA II Age between 25 to 75 years 25 years 75 years Both Any contraindication for spinal anesthesia Obesity (body mass index more than 35 kg/m2) Local infection at the injection site in the groin Previous surgery at the injection site Injecting drug addicts Receiving any type of analgesic two hours before surgery Mental and psychological disorders Multi-trauma fractures A History of severe heart disease A history of kidney and respiratory diseases Liver disease Pregnancy Hematologic disorders G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Iliaca fascia block will beperformed using 20 cc of bupivacaine 0.25% with 0.5 cc of dexmedetomidine 50μg. Control group: Iliaca fascia block will be performed using only 20 cc of bupivacaine 0.25%. Duration of analgesia. Timepoint: The duration of analgesia until the onset of pain felt by the patient in 24 hours after surgery. Method of measurement: timing. Prescribing an analgesic. Timepoint: Prescribing an analgesia in recovery, 2, 6, 12 and 24 hours after surgery. Method of measurement: Patient request. Time to Prescription an analgesic. Timepoint: 24 hours after surgery. Method of measurement: Timing. Pain severity. Timepoint: In recovery, 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analog Scale (VAS). Complications of Iliaca fascia block. Timepoint: In recovery, 2, 6, 12 and 24 hours after surgery. Method of measurement: Clinical examination. Oroumia University of Medical Sciences Approved 2021-10-30 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)