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临床试验/NCT07081867
NCT07081867已完成不适用

Comparison of Postoperative Analgesic Efficacy of Preoperatively Performed Sacral Erector Spinae Plane Block and Supra-Inguinal Fascia Iliaca Block in Patients Undergoing Surgery for Hip Fracture

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2025年1月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Postoperative Pain Scores

研究概览

简要总结

This study compares the postoperative analgesic effectiveness of Sacral Erector Spinae Plane Block (SESPB) and Supra-Inguinal Fascia Iliaca Block (SIFIB) in patients undergoing hip fracture surgery. Both techniques are regional anesthesia methods aiming to reduce postoperative pain and opioid consumption. The study evaluates pain scores, opioid requirements, mobilization times, and hospital discharge times to determine which block provides more effective pain management in different postoperative periods.

详细描述

Hip fractures are common injuries among elderly patients, often resulting in high rates of morbidity and mortality. Effective postoperative pain management plays a critical role in reducing complications such as delayed mobilization, deep vein thrombosis, pneumonia, and prolonged hospitalization.

Regional anesthesia techniques, including Sacral Erector Spinae Plane Block (SESPB) and Supra-Inguinal Fascia Iliaca Block (SIFIB), have gained popularity as part of multimodal analgesia strategies that aim to minimize opioid use and improve postoperative comfort. However, there is limited evidence comparing these two techniques directly.

In this prospective observational study, patients aged 65 and older undergoing hip fracture surgery under spinal anesthesia were included. After obtaining informed consent, patients received either SESPB or SIFIB for postoperative analgesia in addition to the standard anesthetic protocol.

Pain levels were assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Additional data such as total opioid consumption within 24 hours, time to first analgesic requirement, mobilization time, and length of hospital stay were recorded.

The results demonstrated that patients who received SIFIB had significantly lower pain scores in the early postoperative period (1st hour), while patients who received SESPB experienced better pain relief in the late postoperative period (24th hour). No significant differences were observed between the groups in terms of total opioid consumption, mobilization time, or hospital stay duration. No complications related to the block procedures were reported.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 65 years and older
  • Patients undergoing surgery for hip fractures under spinal anesthesia
  • Patients who are oriented and cooperative
  • Patients who have signed an informed consent form

排除标准

  • Patients with contraindications for spinal anesthesia
  • Patients with Alzheimer's disease or dementia, and those who are non-oriented or non-cooperative
  • Patients with major organ failure (such as heart, liver, or kidney failure)
  • Patients who decline to participate in the study
  • Patients classified as American Society of Anesthesiologists (ASA) Physical Status IV or higher
  • Patients with pathological fractures or bone metastasis

研究组 & 干预措施

SIFIB Group

Patients who underwent Supra-Inguinal Fascia Iliaca Block (n=40)

干预措施: Supra-inguinal Fascia Iliaca Block (SIFIB) (Procedure)

SESPB Group

Patients who underwent Sacral Erector Spinae Plane Block (n=37)

干预措施: Sacral Erector Spinae Plane Block (SESPB) (Procedure)

结局指标

主要结局

Postoperative Pain Scores

时间窗: At 1 hour, 6 hours, 12 hours, and 24 hours postoperatively.

Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be recorded at specific postoperative time points: 1st, 6th, 12th, and 24th hours.

Time to First Postoperative Analgesic Requirement

时间窗: Up to 48 hours postoperatively.

Time interval from end of surgery to the first request for analgesia.

Total Postoperative Opioid Consumption

时间窗: A week

The total amount of opioids required by patients during the postoperative period.

Time to First Mobilization

时间窗: From the end of surgery until first mobilization, typically within 24 to 48 hours postoperatively

The time until patients' first mobilization (walking or standing) after surgery.

次要结局

  • Length of Hospital Stay(Up to 14 days postoperatively.)
  • Block-Related Complications(A week)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyzanur Aydoğdu

Resident Doctor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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