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Набор скоро начнётся NCT07370415

mTLIP vs QIPB for Postoperative Analgesia After Lumbar Instrumentation Surgery

Без фазы С лечением Pain, Postoperative

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: Modified Thoracolumbar Interfascial Plane Block (mTLIP), Quadro-Iliac Plane Block (QIPB):.
Кому может быть актуально
Состояния в реестре: Pain, Postoperative. Базовые параметры: 18 лет — 65 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
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Официальное название

Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery

Обзор

Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.

Подробное описание

Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.

Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.

The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.

This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.

Вмешательства

  • Процедура Modified Thoracolumbar Interfascial Plane Block (mTLIP)
    An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
  • Процедура Quadro-Iliac Plane Block (QIPB):
    An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).

Первичные конечные точки

  • Postoperative 48-Hour PCA Opioid Consumption [Срок оценки: Postoperative 0-8, 8-16, 16-24, 24-48 intervals]
Вторичные конечные точки (6)
  • QoR-15 Recovery Score [Срок оценки: Postoperative 24th and 48th hours]
  • Dynamic and static Numeric Rating Scale scores [Срок оценки: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively]
  • Total rescue analgesic dose [Срок оценки: Postoperative 48 hours]
  • Time of first request for rescue analgesia [Срок оценки: Postoperative 48 hours]
  • Length of Hospital Stay [Срок оценки: Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.]
  • Block and Opioid-Related Adverse Effects and Complications [Срок оценки: Postoperative 48 hours]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Classified as American Society of Anesthesiologists physical status I-III
  • Scheduled for elective lumbar instrumentation surgery under general anesthesia
  • Provision of written informed consent

Критерии исключения

  • Use of anticoagulant medications or presence of bleeding diathesis
  • Known allergy or hypersensitivity to local anesthetics or opioid drugs
  • Infection at the planned block site
  • Alcohol or drug dependence
  • Cognitive impairment preventing reliable pain assessment
  • Pregnancy or lactation
  • History of previous lumbar spine surgery
  • Diabetes mellitus
  • Renal or hepatic insufficiency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bursa City Hospital — Nilufer

Публикации

  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018. PMID 38459608
  • Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available. PMID 40160919
  • Ciftci B, Ekinci M. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. Agri. 2020 Nov;32(4):186-192. doi: 10.14744/agri.2020.72325. PMID 33398870

Идентификаторы

NCT: NCT07370415 · BursaCity Hos 3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗