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IRCT20230410057871N1 IRCT 2023-07-09 Khoram-Abad University of Medical Sciences Investigation of the Results of Single-injection Nerve Block Comparison of the Results of Single-Injection Nerve Block with the Traditional Method in Patients Requiring Digital Anesthesia 2023-07-23 anticipated 80 Complete https://irct.ir/trial/71150 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using the Balanced Block Randomization method and the participants will be divided into single-injection or control (traditional injection) groups. N/A Hand surgery. Intervention 1: Intervention group: The single injection method will be performed by injecting 3 ml of 1% lidocaine at the base of the finger in the proximal volar metacarpophalangeal region. In all cases, a 27 G needle will be used. Intervention 2: Control group: The traditional technique will be performed by injecting 1.5 ml of 1% lidocaine without epinephrine in each lateral part of the base of the finger, just distal to the metacarpophalangeal joint, at the level of the web spaces. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Arian Karimi Rouzbahani
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
Khorramabad Iran (Islamic Republic of) 6814993165 +98 930 675 7977 arian.karimi@sbmu.ac.ir Khoram-Abad University of Medical Sciences scientific Mohammad Kazem Shahmoradi
Iran, Lorestan, Khorramabad, Enghelab St
Khorramabad Iran (Islamic Republic of) 68169 33132 +98 66 3323 6401 Shahmoradi.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) All patients requiring hand surgery at Shohada-ye Ashayer Teaching Hospital in Khorramabad. Age 18 years and older 18 years no limit Both Subjects with a history of previous surgery on the ipsilateral hand Subjects who discontinue their cooperation with the research team Treatment - Surgery Treatment - Surgery Intervention group: The single injection method will be performed by injecting 3 ml of 1% lidocaine at the base of the finger in the proximal volar metacarpophalangeal region. In all cases, a 27 G needle will be used. Control group: The traditional technique will be performed by injecting 1.5 ml of 1% lidocaine without epinephrine in each lateral part of the base of the finger, just distal to the metacarpophalangeal joint, at the level of the web spaces. Change in the pain reported by the patient (pain measured by the Visual Analogue Scale). Timepoint: The pain level will be recorded patient at 1, 3, 5, 15, and 20 minutes. Method of measurement: The patient's pain after the injection is measured with a ruler that ranges from 0 to 10 cm so that 0 is the sign of no pain and 10 is the most severe pain ever experienced. Analgesia onset time in patients in the two groups. Timepoint: Minutes 1, 3, 5, 15 and 20. Method of measurement: The level of pain will be recorded at 1, 3, 5, 15, and 20 minutes. The rate of complications caused by the treatment including arterial blood oxygen saturation below 90% for more than 60 seconds, change in pulse rate or blood pressure (increase or decrease), change in respiratory rate (increase or decrease), side effects (nausea and vomiting or loss of consciousness). Timepoint: Minutes 1, 3, 5, 15 and 20. Method of measurement: Arterial blood oxygen saturation will be measured by a pulse oximeter from the first finger of the right or left hand. Any drop below 90% for more than 60 seconds will be considered positive. Its absolute amount will be recorded in the 5 defined times. Overall satisfaction of patients 60 minutes after the end of receiving the medication. Timepoint: Minutes 1, 3, 5, 15 and 20. Method of measurement: Overall satisfaction will be evaluated based on a 5-point scale (0=poor, 1=moderate, 2=good, 3=very good, 4=excellent) within 60 minutes after receiving the medication. Khoram-Abad University of Medical Sciences Approved 2023-02-15 Ethics Committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran Khorramabad Lorestan Iran (Islamic Republic of)