Идёт набор NCT07695987

Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy

Без фазы С лечением Pain Management

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ultrasound-Guided Quadro-Iliac Plane Block, Local Infiltration Analgesia (LIA).
Кому может быть актуально: Состояния в реестре: Pain Management. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial

Обзор

This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy. Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.

Подробное описание

This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.

Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.

All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.

Вмешательства

Процедура Ultrasound-Guided Quadro-Iliac Plane Block
Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
Процедура Local Infiltration Analgesia (LIA)
Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia.

Первичные конечные точки

Total Fentanyl Consumption During the First 24 Hours After Surgery [Срок оценки: Postoperative 0-24 hours]

Вторичные конечные точки (5)

Postoperative Pain Scores at Rest and During Movement [Срок оценки: Postoperative 0, 1, 6, 12, and 24 hours]
Number of Patients Require Rescue Analgesic [Срок оценки: Postoperative 0-24 hours]
Opioid-Related Adverse Effects [Срок оценки: Postoperative 0-24 hours]
Quality of Recovery Score [Срок оценки: Postoperative 24 hours]
Dermatomal Sensory Spread [Срок оценки: Postoperative 2 hours]

Критерии участия

Критерии включения

Adults aged 18 to 75 years
American Society of Anesthesiologists physical status I to III
Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
Planned surgery under general anesthesia
Able to provide written informed consent