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IRCT20131108015322N7 IRCT 2022-10-08 Shahid Beheshti University of Medical Sciences The effect of adding dexmedetomidine and fentanyl to lidocaine on the the quality of infraclavicular peripheral block in upper extremity orthopedic surgery The Comparison of the effect of dexmedetomidine and fentanyl as adjuvant to lidocaine on the onset time and duration of ultrasound guided infraclavicular brachial plexus block in orthopedic upper limb surgery 2022-10-07 anticipated 60 Complete https://irct.ir/trial/65779 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method by a table of random numbers is used to generate a random sequence of patients and participants are randomly assigned to one of the three study groups. To use the table of random numbers, the researcher first determines the direction of reading the numbers in the table. Then numbers 0-20 are considered for the control group, numbers 21-40 for intervention D group, and numbers 41-60 for intervention F group. Then the researcher puts the hand on one of the numbers and moves in the predetermined direction, records the numbers and assigns them to different groups. Each of the randomly assigned sequence numbers are recorded on a card and each card is placed in a sealed numbered envelope with the same card number. When the eligible participants enter the study, the envelopes are selected in order of their sequence and patients receive the intervention of the same group, Blinding description: Randomization and assignment of patients in each group is done by persons with no involvement in the trial. Participants, investigators, care provider and outcome assessors are unaware of the allocation of individuals in each study group.Since the participants, researchers and outcome assessors are unaware of the allocation of the study groups, and the syringes containing the studied drugs are similar in terms of color and volume, this is a double blinded study. 3 Improving the quality of infraclavicular brachial plexus block in terms of the onset and length of sensory and motor block and analgesic effect. Intervention 1: Control group: Receives 19 ml of lidocaine 1.5% with epinephrine 1:200000 + 1 ml of normal saline for infraclavicular block. Intervention 2: Fentanyl group: Receives 19 ml of lidocaine 1.5% with epinephrine 1:200000 + 1 ml containing 50 µg of fentanyl infraclavicular block. Intervention 3: Dexmedetomidine group: Receives 19 ml of lidocaine 1.5% + 1 ml containing 100 µg of dexmedetomidine for infraclavicular block. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Shideh Dabir
Anesthesiology Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2595 shdabir@yahoo.com Shahid Beheshti University of Medical Sciences scientific Shideh dabir
Anesthesiology Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2595 shdabir@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) ASA class1 and 2 unilateral upper limb surgery age 15-75 years patient's acceptance 15 years 75 years Both ASA class≥3 Allergy to local anesthetics Age more than 75 yrs and less than 15 yrs Coagulation disorders Opium addiction Infection at the block site BMI >30 liver or kidney failure chronic use of painkillers and narcotics patients who take narcotics before surgery pregnancy Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Receives 19 ml of lidocaine 1.5% with epinephrine 1:200000 + 1 ml of normal saline for infraclavicular block. Fentanyl group: Receives 19 ml of lidocaine 1.5% with epinephrine 1:200000 + 1 ml containing 50 µg of fentanyl infraclavicular block. Dexmedetomidine group: Receives 19 ml of lidocaine 1.5% + 1 ml containing 100 µg of dexmedetomidine for infraclavicular block. The onset time of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale. The onset time of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3. Duration of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale. Duration of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3. Heart rate. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Electrocardiogram, Pulse oximeter. Systolic blood pressure. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Noninvasive Blood pressure measurement method. Sedation level. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Sedation scale with a rating of 1-4. Pain severity. Timepoint: 10, 20 and 30 minutes after the start of the operation, 5, 10 and 15 minutes after entering the recovery and 3, 12 and 24 hours after operation. Method of measurement: A 5-point verbal rating scale (VRS) consisting of (0 =no pain, 4=unbearable pain). Total number of patient’s requests for systemic analgesics. Timepoint: In the first 24 hours after operation. Method of measurement: Recording the number of requests for analgesic. Shahid Beheshti University of Medical Sciences Approved 2021-10-26 Research Ethics Committee of shahid Beheshti University of Medical Sciences Building no. 2, 6th floor, Office of Research Affairs, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)