跳至主要内容
临床试验/NCT07452120
NCT07452120尚未招募不适用

Comparison of the Effects of Deep Iliacus Plane Block (DIPB) and Suprainguinal Fascia Iliaca Block (SIFIB) on Postoperative Analgesia in Patients Undergoing Hip Surgery: A Randomized Controlled Study

Sivas Numune Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

This randomized, double-blind clinical trial aims to compare the effectiveness of the Deep Iliacus Plane Block (DIPB) and the Suprainguinal Fascia Iliaca Block (SIFIB) for postoperative pain control in patients undergoing primary total hip arthroplasty. Effective analgesia after hip surgery is essential for early mobilization, reduction of complications, and improved recovery outcomes.

Seventy patients scheduled for elective hip arthroplasty under spinal anesthesia will be randomly assigned to receive either DIPB or SIFIB at the end of surgery. Postoperative pain scores, opioid consumption, motor block, and block-related complications will be evaluated over a 48-hour period.

The study aims to determine whether DIPB provides superior or comparable analgesia with reduced motor blockade compared to SIFIB, thereby contributing to safer and more comprehensive postoperative pain management in hip surgery patients.

详细描述

Hip arthroplasty is frequently associated with moderate to severe postoperative pain, which may negatively affect early mobilization, rehabilitation, and overall recovery. Adequate postoperative analgesia is therefore essential to reduce complications such as pulmonary morbidity, thromboembolism, delirium, and prolonged hospital stay.

The hip joint is innervated by both deep articular branches (femoral, obturator, and accessory obturator nerves) and superficial cutaneous branches (femoral nerve and lateral femoral cutaneous nerve). An optimal regional analgesic technique should provide effective blockade of both components. However, currently used techniques often fail to adequately block deep capsular innervation while preserving motor function.

The suprainguinal fascia iliaca block (SIFIB) is widely used in hip surgery and effectively blocks the femoral nerve and lateral femoral cutaneous nerve, providing reliable cutaneous analgesia. Nevertheless, insufficient spread to obturator and accessory obturator nerves may result in inadequate deep joint analgesia. Attempts to overcome this limitation using high-volume injections may increase the risk of quadriceps weakness and motor blockade.

The Deep Iliacus Plane Block (DIPB) is a recently described fascial plane block targeting the deep surface of the iliacus muscle at the level of the anterior inferior iliac spine. Anatomical and preliminary clinical findings suggest that DIPB allows spread of local anesthetic to femoral, lateral femoral cutaneous, and pericapsular articular branches of the hip joint, potentially providing both capsular and cutaneous analgesia with reduced motor impairment. DIPB has therefore been proposed as a hybrid technique combining advantages of existing regional blocks.

This prospective, randomized, controlled, double-blind clinical trial will be conducted at Sivas Numune Hospital. Seventy patients (ASA I-III) scheduled for elective primary total hip arthroplasty under spinal anesthesia will be enrolled and randomly assigned into two groups: the SIFIB group (n=35) and the DIPB group (n=35). Randomization will be performed using a computer-generated sequence.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged ≥18 years
  • ASA physical status I-III
  • Scheduled for elective primary total hip arthroplasty under spinal anesthesia
  • Ability to understand the study procedures and provide informed consent

排除标准

  • Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
  • Infection at the block application site
  • Hemodynamic instability
  • Known allergy to local anesthetics
  • Pre-existing significant neurological or motor deficits in the lower extremities
  • Cognitive impairment preventing pain assessment
  • Refusal to participate or inability to provide informed consent

研究组 & 干预措施

Suprainguinal Fascia Iliaca Block (SIFIB)

Experimental

Participants randomized to this arm will receive an ultrasound-guided suprainguinal fascia iliaca compartment block at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.

干预措施: Suprainguinal Fascia Iliaca Block (Procedure)

Deep Iliacus Plane Block (DIPB)

Experimental

Participants randomized to this arm will receive an ultrasound-guided deep iliacus plane block at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.

干预措施: Deep Iliacus Plane Block (Procedure)

结局指标

主要结局

Postoperative pain intensity

时间窗: 2, 4, 8, 16, 24, and 48 hours postoperatively

Postoperative pain assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at rest and during movement following total hip arthroplasty.

次要结局

  • Opioid consumption(From the end of surgery to 48 hours postoperatively)
  • Motor block(4, 8, 16, 24, and 48 hours postoperatively)
  • Pain during movement(2, 4, 8, 16, 24, and 48 hours postoperatively)

研究者

发起方
Sivas Numune Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fatih Balcı

Specialist physician

Sivas Numune Hospital

研究点 (1)

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