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IRCT20251028067791N1 IRCT 2025-11-13 Iran University of Medical Sciences Comparison of two type of anesthesia on pain intensity in PCNL surgery. Comparison of erector spinae block and paravertebral block using ropivacaine on pain intensity and need for analgesics after percutaneous nephrolithotomy in patients of Firoozgar Hospital. 2025-11-22 anticipated 92 Recruiting https://irct.ir/trial/87156 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: "My study is being conducted at a single center and aims to compare the effectiveness of two types of pain blocks in reducing the need for analgesics after nephrolithotomy. Therefore, the study design is single-center and aims to investigate the superiority of one method over the other.", Randomization description: Patients will be randomly assigned to one of the two groups (paravertebral block or quadratus lumborum block) using a random number table (or computer-generated randomization). The allocation will be performed by a person not involved in the intervention or outcome assessment. N/A postoperative pain after nephrolithotomy. Intervention 1: Intervention group: Ultrasound-guided Erector Spinae Plane Block (ESP block)with Ropivacaine 0.2%, volume 20-30 ml, administered preoperatively at the level of T8-T9 on the side of surgery. Intervention 2: Intervention group: Ultrasound-guided Paravertebral Block with Ropivacaine 0.2%, volume 20-30 ml, administered preoperatively at the level of T10-T11 on the side of surgery. 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 Since this study is part of a resident thesis with limited scope and duration, there is currently no plan or requirement to share individual participant data. The dataset is small, and the primary goal is academic fulfillment, not broader data dissemination.
public Dr Robab maghsoudi
Vanak Square, Shahid Valinejad Street, No. 11, Unit 6
Tehran Iran (Islamic Republic of) 1416733151 +98 914 411 0966 rmaghsudy@yahoo.com Iran University of Medical Sciences scientific Dr. Robab maghsoudi
Tehran, Vanak Square, Shahid Valinejad Street, No. 11, Unit 6
Tehran Iran (Islamic Republic of) 1517963717 +98 914 411 0966 rmaghsudy@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) The patient's age is between 20 - 65. BMI <30 should be less than Not be addicted to drugs Do not take painkillers 48 hours before the procedure. The duration of the procedure should be less than 3 hours. 20 years 65 years Both The patient is older than 65 and younger than 20 The patient's BMI is greater than 30. Have a drug addiction If you have taken painkillers 48 hours before the procedure If the procedure lasts more than 3 hours N20 Calculus of kidney and ureter Treatment - Drugs Treatment - Drugs Intervention group: Ultrasound-guided Erector Spinae Plane Block (ESP block)with Ropivacaine 0.2%, volume 20-30 ml, administered preoperatively at the level of T8-T9 on the side of surgery. Intervention group: Ultrasound-guided Paravertebral Block with Ropivacaine 0.2%, volume 20-30 ml, administered preoperatively at the level of T10-T11 on the side of surgery. *Pain intensity* measured by Visual Analog Scale (VAS) at defined postoperative intervals (e.g., 2, 6, 12, 24 hours) - *Total analgesic consumption* (e.g., mg of morphine or equivalent) within the first 24 hours after surgery. Timepoint: At 1, 6, 12, and 24 hours postoperative and cumulative analgesic consumption within 24 hours after surgery. Method of measurement: 1: Visual Analog Scale (VAS), a 10-cm scale where 0 indicates no pain and 10 indicates worst imaginable pain. 2:Total amount of analgesic drugs (e.g., morphine equivalents) recorded from patient charts during the first 24 hours postoperatively. 1: Patient satisfaction level with pain control 2: Occurrence of complications related to the block (e.g. hypotension, nausea) 3: Time of first request for analgesics 4: Changes in vital signs after the block. Timepoint: at 1, 6, 12, and 24 hour postoperative. Method of measurement: 1.Patient satisfaction: Measured using a standardized 5-point Liker scale questionnaire postoperatively. 2.Complications (e.g., hypotension, nausea): Monitored and recorded by clinical observation and chart review.3.Time to first analgesic request: Recorded in hours from end of surgery until the first analgesic demand by patient, via nursing chart. 4.Vital signs: Measured using standard hospital monitoring equipment (blood pressure, heart rate, respiratory rate) and recorded at regular intervals postoperatively. Iran University of Medical Sciences Approved 2025-10-25 Ethics Committee in Research, Faculty of Medicine - Iran University of Medical Sciences Vali Asr Square, Shahamati Alley, No. 11, Unit 5 Tehran Tehran Iran (Islamic Republic of)