]>
IRCT20250422065437N1 IRCT 2025-09-16 Tehran University of Medical Sciences The comparative efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in infraclavicular block The comparative efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in ultrasound guided infraclavicular block in patients with upper limb fractures: A randomized clinical trial 2025-09-23 anticipated 80 Complete https://irct.ir/trial/83350 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to either Group A (bupivacaine 0.5%) or Group B (a combination of bupivacaine 0.5% and lidocaine 2%) through the website www.randomization.com. Simple randomization will be conducted at an individualized level. After randomization, the results will be placed in concealed, opaque envelopes. An anesthesiology technician who is not involved in this study and is responsible for drug preparation will open these envelopes. The technician will prepare the drug outside of the operation room and prefilled syringes will be given to anesthesiologist. The prepared drugs are similar in term of the color and volume. The surgeon, patients, and anesthesiologist will remain blinded to the drugs used in the study, Blinding description: After randomization, the results will be placed in concealed, opaque envelopes. An anesthesiology technician who is not involved in this study and is responsible for drug preparation will open these envelopes. The technician will prepare the drug outside of the operation room and prefilled syringes will be given to anesthesiologist. The prepared drugs are similar in term of the color and volume. The surgeon, patients, and anesthesiologist will remain blinded to the drugs used in the study. 2-3 Upper limb fractures. Intervention 1: Control group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% will be injected around the medial, lateral and posterior cords. Intervention 2: Intervention group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% in combination with 10 ml of Lidocaine 2% will be injected around the medial, lateral and posterior cords. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: 6 months after publication of the paper To whom: People working in academic institutions Conditions: The analized data can only be used in purpose of designing similar studies or review articles. Where to obtain: Dr Pouya Sharifi; 00989114582017 pouya.srf94@gmail.com How to obtain: Please send your request via SMS or Email to Dr Sharifi. The information will be available in 1 or 2 weeks. Comments:
public Pouya Sharifi
No 6, Mokhtari avenue, Khojastepoor street, Bagh Feiz
Tehran Iran (Islamic Republic of) 1114713135 +98 905 458 2517 pouyasrf94@gmail.com Tehran University of Medical Sciences scientific Pouya Sharifi
No 6, Mokhtari avenue, Khojastepoor street, Bagh Feiz
Tehran Iran (Islamic Republic of) 11114713135 +98 905 458 2517 pouyasrf94@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 Body mass index (BMI) ranging from 20 to 35 kg/m² Upper limb fracture 18 years 65 years Both Requiring more than one fixation in the affected limb Allergy to opioids, acetaminophen, local anesthetics and nsaids Patients with chronic pain syndromes Patients abusing alcohol, opioids ant other anti legal drugs Renal dysfunction (edema, shortness of breath, malaise, hematuria, insomnia) Hepatic dysfunction (jaundice, ascitis, loss of consciousness, malaise, nausa, vomiting) Patients with neuromuscular disease Patients with psychological disease Loss of consciousness Pregnancy Infection at the site of procedure Patients with coagulation disease or taking anti-coagulant agents except Aspirin Reluctance to participation in this study T10 Fracture of upper limb, level unspecified Treatment - Other Treatment - Other Control group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% will be injected around the medial, lateral and posterior cords. Intervention group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% in combination with 10 ml of Lidocaine 2% will be injected around the medial, lateral and posterior cords. Onset of complete sensory block. Timepoint: Every 1 minute up to 10 minutes, every 2 minutes up to 10 minutes and then every 5 minutes up to 10 minutes or complete anethesia. Method of measurement: Hollman scale with pinprick test. Onset of complete motor block. Timepoint: Every 5 minutes up to 30 minutes. Method of measurement: Physical examination of thumb abduction (radial nerve), third finger flexion (median nerve), fifth finger flexion (ulnar nerve) and elbow flexion (musculocutaneous). Duration of sensory block. Timepoint: Every 5 minutes after the onset of complete sensory block. Method of measurement: Time between the onset of complete sensory block to first sensation of pain or patient request for painkillers. Duration of motor block. Timepoint: Every 5 minutes after the onset of complete motor block. Method of measurement: Time between the onset of complete motor block to return of finger functions (Grade 2 in Hollmen Scale). Tehran University of Medical Sciences Approved 2024-02-13 Ethics committee of Tehran University of Medical Sciences Shariati hospital, the intersection of South Kargar street and Jalal-e-Aal-e- Ahmad boulevard Tehran Tehran Iran (Islamic Republic of)