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IRCT20230204057318N7 IRCT 2024-12-17 Shahid Beheshti University of Medical Sciences Comparison of direct injection and PENG Comparison of direct injection of Ropivacaine around the hip joint with pericapsular nerve group block (PENG) on opium consumption around the operation in patients undergoing Total hip Arthroplasty 2024-12-21 anticipated 128 Complete https://irct.ir/trial/80716 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Creating a random sequence using a simple randomization method using 120 cards (60 cards for each group) that are placed inside opaque sealed envelopes and will be shuffled by the patients before choosing, Blinding description: The patients and the person responsible for data collection and the person analyzing will be unaware of the coding. Only the anesthesiologist and orthopedic surgeon will be aware of the patient's group during surgery and will perform coding for each group. 3 Pericapsular nerve group block. Intervention 1: Intervention group: The method of inducing analgesia will be the PENG method, in which 20 ml of 0.25% ropivacaine will be injected laterally to medially with a standard 100 mm, 22-gauge needle at the level between the tendon of the psoas muscle and the ramus pubis. Intervention 2: Intervention group: 20 cc of 0.25% ropivacaine will be used and injected as a 5 ml injection into the ligamentum teres before stem placement, a five ml injection into the labrum after stem placement, and the remaining ten ml injection after capsular repair (5 ml into the capsule, 5 ml into the muscle). 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 All data is potentially shareable after de-identifying individuals.
public Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences scientific Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidate for total hip arthroplasty 50 years 75 years Both No history of pelvic surgery No history of drug abuse and other psychoactive substances No history of psychiatric disease No allergy to local anesthetics Unwillingness to participate in the study Treatment - Surgery Treatment - Surgery Intervention group: The method of inducing analgesia will be the PENG method, in which 20 ml of 0.25% ropivacaine will be injected laterally to medially with a standard 100 mm, 22-gauge needle at the level between the tendon of the psoas muscle and the ramus pubis. Intervention group: 20 cc of 0.25% ropivacaine will be used and injected as a 5 ml injection into the ligamentum teres before stem placement, a five ml injection into the labrum after stem placement, and the remaining ten ml injection after capsular repair (5 ml into the capsule, 5 ml into the muscle). Pain. Timepoint: At the times of entry to post-anesthesia care unit, 2, 6, 12, and 24 hours. Method of measurement: Visual Analogue Scale (VAS). Total postoperative opioid consumption in 24h. Timepoint: After 24h. Method of measurement: Consumption volume of patient controlled analgesia (PCA) pump. Shahid Beheshti University of Medical Sciences Approved 2024-12-03 Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)