Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block for Pain Management After Total Hip Arthroplasty: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative 24-Hour Morphine PCA Consumption
研究概览
简要总结
This prospective, randomized, double-blind study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane (QIP) block in patients undergoing primary total hip arthroplasty. The QIP block is a recently described fascial plane block. Patients will be randomized to receive either a QIP block with local anesthetic or a sham block with saline. The primary outcome is 24-hour opioid consumption. Secondary outcomes include motor block, dermatomal sensory assessment, pain scores, rescue analgesic requirement, quality of recovery (QoR-15), and opioid-related side effects.
详细描述
Total hip arthroplasty is associated with significant postoperative pain. The Quadro-Iliac Plane (QIP) block is a recently described fascial plane block targeting the area where the quadratus lumborum muscle attaches to the iliac crest and may provide more comprehensive analgesia. This study is designed as a prospective, randomized, double-blind clinical trial including patients aged 18-80 years with ASA physical status I-III undergoing elective primary total hip arthroplasty.
Patients will be randomized into two groups. The QIP group will receive an ultrasound-guided QIP block with 40 mL of 0.25% local anesthetic solution containing epinephrine, and the control group will receive a sham block with 40 mL of 0.9% NaCl using the same technique. The primary outcome is postoperative 24-hour opioid consumption. Secondary outcomes include motor block, and dermatomal sensory assessment, pain scores, quality of recovery (QoR-15), rescue analgesic requirement and opioid-related side effects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study solutions will be prepared by an anesthesiologist who is not involved in patient care or data collection. The anesthesiologist performing the block and the patient will be blinded to group allocation. Postoperative assessments will be performed by an independent anesthesiologist who is also blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-III
- •Age between 18 and 80 years
- •Patients scheduled for elective primary total hip arthroplasty
排除标准
- •Refusal to participate in the study
- •Allergy to local anesthetics or opioids
- •Known or suspected coagulopathy
- •Infection at the injection site
- •History of previous hip surgery
- •Severe cardiovascular disease
- •Liver or kidney failure
- •Pregnancy, suspected pregnancy, or breastfeeding
- •Severe neurological or psychiatric disorder
- •Chronic opioid use
研究组 & 干预措施
Quadro-Iliac Plane (QIP) Block
Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, an ultrasound-guided Quadro-Iliac Plane (QIP) block will be performed in the preoperative period with the patient in the lateral decubitus position. The technique aims to provide postoperative analgesia by achieving sensory blockade in the relevant dermatomal areas.
干预措施: Quadro-Iliac Plane (QIP) Block (Procedure)
Sham Block (Control)
Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, a sham block will be performed using the same ultrasound-guided technique and patient positioning to mimic the block procedure without providing active regional anesthesia.
干预措施: Sham Block (Procedure)
结局指标
主要结局
Postoperative 24-Hour Morphine PCA Consumption
时间窗: Postoperative 24 hours
Total amount of morphine delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).
次要结局
- NRS Pain Scores at Rest and Movement(2, 6, 12, 24, and 48 hours postoperatively)
- QoR-15 Recovery Score(QoR-15 Recovery Score will be evaluated at the postoperative 48th hour)
- Lower Extremity Muscle Strength Score(Postoperative 6th and 12th hours)
- Rescue Analgesic Requirement(Postoperative 0-48 hours)
- Opioid-Related Side Effects(Postoperative 0-48 hours)
研究者
Mursel Ekinci
Assoc Prof
Bursa City Hospital