Analgesic Efficacy of Ultrasound-Guided Deep Iliacus Plane Block in Patients Undergoing Hip Fracture Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 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 commonly associated with moderate to severe postoperative pain, which may delay mobilization and increase the need for opioid analgesics. The deep iliacus plane block is a recently described ultrasound-guided regional anesthesia technique designed to provide analgesia by allowing local anesthetic spread toward the femoral nerve, lateral femoral cutaneous nerve, and articular branches supplying the hip.
This prospective, randomized, double-blind, sham-controlled clinical trial will evaluate the analgesic efficacy of the deep iliacus plane block in adult patients undergoing hip fracture surgery under spinal anesthesia. After surgery, participants will be randomly assigned to receive either an ultrasound-guided deep iliacus plane block with local anesthetic or a sham block with normal saline.
All participants will receive standardized multimodal postoperative analgesia, including patient-controlled analgesia. The primary objective is to determine whether the deep iliacus plane block reduces postoperative opioid consumption during the first 24 hours after surgery. Postoperative pain scores, rescue analgesic requirements, sensory distribution, motor block, nausea and vomiting, quality of recovery, patient satisfaction, and block-related complications will also be evaluated.
详细描述
This study is designed as a prospective, randomized, double-blind, sham-controlled clinical trial involving adult patients undergoing hip fracture surgery under spinal anesthesia.
Eligible participants will receive standard monitoring in accordance with the American Society of Anesthesiologists recommendations, including electrocardiography, noninvasive blood pressure measurement, and pulse oximetry. Spinal anesthesia will be performed under sterile conditions at the L3-L4 intervertebral level using 15 mg of isobaric bupivacaine.
Following completion of surgery, while the sensory effects of spinal anesthesia are still present, participants will be randomly allocated to one of two parallel study groups. Randomization will be performed using a computer-generated allocation sequence, and group assignments will be concealed using sequentially prepared sealed envelopes.
Participants assigned to the intervention group will receive an ultrasound-guided deep iliacus plane block on the surgical side. A low-frequency curvilinear ultrasound transducer will be positioned over the anterior hip region to identify the anterior inferior iliac spine, iliopubic eminence, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures. After identification of the target plane between the iliopsoas muscle and the anterior inferior iliac spine, a peripheral nerve block needle will be advanced using an in-plane approach. Following confirmation of appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered.
Participants assigned to the control group will undergo an identical ultrasound-guided procedure and will receive 30 mL of normal saline as a sham block. Participants and postoperative outcome assessors will remain blinded to group allocation. The anesthesiologist performing the study intervention will not participate in postoperative outcome assessment.
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)
盲法说明
Participants and postoperative outcome assessors will be masked to group allocation. Both groups will undergo an identical ultrasound-guided deep iliacus plane block procedure. The anesthesiologist performing the block will be aware of the allocated intervention but will not participate in postoperative outcome assessment. Group allocation will remain concealed from participants and outcome assessors until completion of data collection, except when emergency unmasking is required for participant safety.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Scheduled to undergo unilateral hip fracture surgery under spinal anesthesia
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Ability to understand and use the Numerical Rating Scale and patient-controlled analgesia device
- •No contraindication to spinal anesthesia or the deep iliacus plane block
- •Written informed consent provided by the participant or legally authorized representative
排除标准
- •ASA physical status IV or higher
- •Emergency surgery
- •Coagulopathy, bleeding diathesis, or anticoagulant treatment that contraindicates spinal anesthesia or peripheral nerve block
- •Infection at the planned needle insertion site
- •Known allergy to local anesthetics or any study medication
- •Pre-existing peripheral neuropathy, neurological disorder, or motor deficit involving the operated lower extremity
- •Inability to understand or use the Numerical Rating Scale or patient-controlled analgesia device
- •Cognitive impairment or communication difficulty preventing reliable postoperative assessment
- •Refusal to participate
研究组 & 干预措施
Sham Control Group
Participants assigned to this group will undergo an identical ultrasound-guided deep iliacus plane block procedure on the surgical side and will receive 30 mL of normal saline as a sham intervention. All participants will also receive standardized spinal anesthesia and the same multimodal postoperative analgesic regimen, including intravenous patient-controlled analgesia with tramadol.
干预措施: Sham Deep Iliacus Plane Block With Normal Saline (Procedure)
Deep Ilacus plane block group
Participants assigned to this group will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side after completion of hip fracture surgery. The block will be performed using 30 mL of 0.25% bupivacaine. All participants will also receive standardized spinal anesthesia and multimodal postoperative analgesia, including intravenous patient-controlled analgesia with tramadol.
干预措施: Ultrasound-Guided Deep Iliacus Plane Block With Bupivacaine (Procedure)
结局指标
主要结局
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
时间窗: From completion of surgery to postoperative hour 24
The total amount of tramadol, expressed in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 hours after surgery will be recorded. The patient-controlled analgesia solution will contain tramadol at a concentration of 4 mg/mL, with a 20 mg bolus dose, a 20-minute lockout interval, no background infusion, and a maximum limit of 200 mg over four hours. Lower cumulative consumption indicates a lower postoperative opioid requirement.
次要结局
- Postoperative Numerical Rating Scale Pain Scores at Rest(At postoperative hours 1, 6, 12, and 24)
- Postoperative Numerical Rating Scale Pain Scores During Movement(At postoperative hours 1, 6, 12, and 24)
- Requirement for Rescue Analgesia During the First 24 Postoperative Hours(During the first 24 postoperative hours)
- Cumulative Dexketoprofen Consumption During the First 24 Postoperative Hours(During the first 24 postoperative hours)
- Dermatomal Distribution of Sensory Blockade Assessed by Cold Sensation(At postoperative hour 2)
- Incidence of Postoperative Nausea and Vomiting(During the first 24 postoperative hours, assessed at hours 1, 6, 12, and 24)
- Quality of Recovery-15 Score at 24 Hours After Surgery(At postoperative hour 24)
- Incidence of Postoperative Motor Block(At postoperative hours 6 and 24)
研究者
Engin Ihsan Turan
principal investigator
Kanuni Sultan Suleyman Training and Research Hospital