Набор скоро начнётся NCT07609212

TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery

Без фазы С лечением Postoperative Pain Spinal Fusion Surgery Degenerative Lumbar Spine Diseases

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: Thoracolumbar interfascial plane block, Retrolaminar block.
Кому может быть актуально: Состояния в реестре: Postoperative Pain, Spinal Fusion Surgery, Degenerative Lumbar Spine Diseases. 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial

Обзор

This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption. Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures. The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.

Подробное описание

This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.

Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.

Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.

All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.

The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.

Вмешательства

Процедура Thoracolumbar interfascial plane block
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
Процедура Retrolaminar block
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.

Первичные конечные точки

Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (7)

Pain intensity using Visual Analog Scale (VAS) [Срок оценки: 30 minutes, 2, 6, 12, and 24 hours postoperatively]
Time to first rescue analgesia [Срок оценки: Within 24 hours postoperatively]
Total nalbuphine consumption [Срок оценки: 24 hours postoperatively]
Time to first ambulation [Срок оценки: From end of surgery to first ambulation, assessed up to 48 hours postoperatively]
Time to tolerate oral intake [Срок оценки: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively]
Length of hospital stay [Срок оценки: From surgery until hospital discharge, assessed up to 7 days postoperatively]
Incidence of postoperative complications [Срок оценки: Within 24-48 hours postoperatively]

Критерии участия

Критерии включения

Adult patients aged 18-65 years
Male and female patients
Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
ASA physical status I-III
BMI < 35 kg/m²
Willing to participate and provide informed consent