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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cumulative Tramadol Consumption During the First 24 Postoperative Hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcome assessors, and investigators involved in postoperative data collection and statistical analysis will be blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments or data analysis.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
时间窗: 24 hours after surgery
The total amount of tramadol administered during the first 24 postoperative hours will be recorded and compared among the study groups.
次要结局
- Postoperative Pain Intensity at Rest(At 0, 2, 6, 12, and 24 hours after surgery)
- Time to First Rescue Analgesia(Within the first 24 hours after surgery)
- Rescue Analgesic Requirement(Within the first 24 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting(Within the first 24 hours after surgery)
- Quality of Recovery-15 (QoR-15) Score(24 hours after surgery)
- Patient Satisfaction Score(24 hours after surgery)
- Block-related Complications(During the first 24 hours after surgery.)