Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption Within the First 24 Hours Postoperatively
研究概览
简要总结
The goal of this clinical trial is to learn whether the Quadroiliac Plane (QIP) block helps reduce postoperative opioid use in adults undergoing femur fracture surgery. It will also evaluate the pain control effectiveness, dermatomal spread, and safety of the QIP block. The main questions it aims to answer are:
Does the QIP block reduce total opioid (fentanyl) consumption within 24 hours after surgery?
Does the QIP block reduce the need for rescue analgesia?
What is the extent of dermatomal spread and are there any side effects or complications?
Researchers will compare patients receiving the QIP block to those receiving standard care without a block to see if the QIP block improves pain management outcomes.
Participants will:
Undergo femur fracture surgery under spinal anesthesia
Be randomly assigned to receive either the QIP block or no block after surgery
Use a patient-controlled analgesia (PCA) device with fentanyl
Have their pain scores, drug use, and recovery quality measured over 24 hours
Undergo a cold test at 2 hours post-op and complete a recovery questionnaire at 24 hours
详细描述
This is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the postoperative analgesic efficacy of the Quadroiliac Plane (QIP) block in patients undergoing femur fracture surgery, specifically partial hip arthroplasty under spinal anesthesia. The primary objective of the study is to assess the impact of the QIP block on total opioid consumption (fentanyl via PCA) during the first 24 hours postoperatively. Secondary objectives include evaluation of rescue analgesia needs, dermatomal spread of the block, incidence of motor block or complications, block feasibility and application time, patient satisfaction, and length of hospital stay.
Eligible participants aged 18 years or older who are scheduled for elective partial hip arthroplasty due to femoral neck fracture and meet inclusion criteria will be invited to participate. After obtaining written informed consent, patients will be randomly assigned to one of two groups using a computer-generated sequence and sealed envelope method. The intervention group will receive a QIP block postoperatively using 40 mL of 0.25% bupivacaine under ultrasound guidance. The control group will receive no regional block. Both groups will receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.
Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain), at rest and with movement at 0, 6, 12, and 24 hours postoperatively. Rescue analgesia (50 mg dexketoprofen IV over 20 minutes) will be administered if needed. The dermatomal spread of the block will be evaluated using an alcohol-based cold test at 2 hours postoperatively. At 24 hours, all patients will complete the Quality of Recovery-15 (QOR-15) questionnaire, which scores recovery from 0 (poor recovery) to 150 (excellent recovery).
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
- Single (Outcomes Assessor)
盲法说明
Pain assessments, including Numerical Rating Scale (NRS) scores, cold test evaluations, and Quality of Recovery-15 (QOR-15) questionnaires, will be performed by outcome assessors who are blinded to the group allocation. These assessors will not be involved in the administration of the Quadroiliac Plane (QIP) block and will be unaware of whether the patient received the block or not. This ensures unbiased evaluation of analgesic outcomes.
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
- •Adults aged 18 years and older
- •Scheduled for partial hip arthroplasty due to femur fracture
- •ASA physical status classification I to III
- •No contraindications to regional anesthesia or study medications
- •Capable of understanding and using patient-controlled analgesia (PCA)
- •Provided written informed consent
排除标准
- •ASA classification IV or higher
- •History of bleeding disorders or use of anticoagulant therapy
- •Known allergy to local anesthetics
- •Presence of neuropathic pain disorders
- •Undergoing emergency surgery
- •Unable to operate PCA device
- •Declined to participate or refused consent
结局指标
主要结局
Total Opioid Consumption Within the First 24 Hours Postoperatively
时间窗: 24 hours postoperatively
The total amount of fentanyl (in micrograms) administered via intravenous patient-controlled analgesia (PCA) will be recorded during the first 24 hours after surgery. This will be used to assess the analgesic efficacy of the Quadroiliac Plane (QIP) block compared to standard care without a block.
次要结局
- Rescue Analgesia Requirement(24 hours)
- Pain Scores at Rest and on Movement(0,6,12 and 24 hours)
- Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block(2 hours postoperatively)
- Postoperative Recovery Quality(24 hours postoperatively)
- Block-Related Complications(24 hours)
研究者
Engin Ihsan Turan
anesthesiology and reanimation specialist
Kanuni Sultan Suleyman Training and Research Hospital