Comparison of Three Analgesic Strategies for Hip Fracture Surgery

Официальное название

Comparison of the Postoperative Analgesic Efficacy of Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, and Standard Analgesia Protocol in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind, Controlled Trial

Обзор

Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. This prospective, randomized, double-blind, controlled trial aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. The primary outcome is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcome measures include postoperative pain intensity, rescue analgesic requirement, incidence of postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) score, and patient satisfaction score.

Подробное описание

Hip fracture surgery is frequently associated with severe postoperative pain, delayed mobilization, and increased opioid consumption. Regional anesthesia techniques have been increasingly used to improve postoperative analgesia and reduce opioid-related adverse effects.

This prospective, randomized, double-blind, controlled, multicenter study aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. Patients will be randomly allocated in a 1:1:1 ratio to one of the three study groups.

All surgical procedures will be performed under spinal anesthesia. Patients assigned to the QIPB group will receive ultrasound-guided quadro-iliac plane block, whereas patients assigned to the SIFIB group will receive ultrasound-guided suprainguinal fascia iliaca block. Patients in the control group will receive standard multimodal analgesia without a regional block.

The primary outcome measure is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, quality of recovery assessed with the Quality of Recovery-15 (QoR-15) questionnaire, patient satisfaction, intraoperative opioid consumption, and block-related complications.

The study is planned to enroll 90 patients across three centers.

Вмешательства

• Процедура Quadro-Iliac Plane Block
  Ultrasound-guided quadro-iliac plane block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
• Процедура Suprainguinal Fascia Iliaca Block
  Ultrasound-guided suprainguinal fascia iliaca block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
• Другое Standard Multimodal Analgesia
  Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

Первичные конечные точки

• Cumulative Tramadol Consumption During the First 24 Postoperative Hours [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (7)

• Postoperative Pain Intensity at Rest [Срок оценки: At 0, 2, 6, 12, and 24 hours after surgery]
• Time to First Rescue Analgesia [Срок оценки: Within the first 24 hours after surgery]
• Rescue Analgesic Requirement [Срок оценки: Within the first 24 hours after surgery]
• Incidence of Postoperative Nausea and Vomiting [Срок оценки: Within the first 24 hours after surgery]
• Quality of Recovery-15 (QoR-15) Score [Срок оценки: 24 hours after surgery]
• Patient Satisfaction Score [Срок оценки: 24 hours after surgery]
• Block-related Complications [Срок оценки: During the first 24 hours after surgery.]

Критерии участия

Критерии включения

• Adult patients aged 18 years or older
• Patients scheduled for hip fracture surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III
• Provision of written informed consent

Критерии исключения

• Refusal to participate
• Contraindications to spinal anesthesia
• Contraindications to regional anesthesia
• Allergy to local anesthetics or study medications
• Infection at the injection site
• Coagulopathy or anticoagulant therapy precluding regional block
• Cognitive impairment preventing pain assessment
• Chronic opioid use
• Revision surgery

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam and Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07676734 · HIP-QIPB-SIFIB-2026 · 105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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