Evaluation of the Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block in Postoperative Analgesia Management Following Lumbar Instrumentation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative 48-Hour PCA Opioid Consumption
研究概览
简要总结
Lumbar instrumentation surgery is associated with significant postoperative pain. This study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery, aiming to assess the efficacy of this newly developed technique for postoperative pain management.
详细描述
Lumbar instrumentation surgery is associated with significant postoperative pain, which may reduce patient comfort, delay early mobilization, and increase analgesic requirements. Effective postoperative pain management is essential for enhancing recovery and reducing postoperative morbidity. In this context, regional anesthesia techniques have become an important component of multimodal analgesia strategies.
The Quadro-Iliac Plane Block is a newly described ultrasound-guided regional analgesia technique. This block aims to provide effective analgesia by targeting the relevant branches of the lumbar nerves supplying the surgical area. However, clinical evidence regarding its effectiveness in postoperative analgesia following lumbar instrumentation surgery remains limited.
This study aims to evaluate the postoperative analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery. The findings of this study are expected to contribute to the assessment of this newly developed technique as a safe and effective option for postoperative pain management in lumbar spine surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classified as American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective lumbar instrumentation surgery
- •Surgery performed under general anesthesia
- •Provision of written informed consent
排除标准
- •Use of anticoagulant or antiplatelet medications
- •Presence of bleeding diathesis or coagulation disorders
- •Known allergy or hypersensitivity to local anesthetics or opioid medications
- •Infection at the planned block site
- •Alcohol or drug dependence
- •Cognitive impairment preventing reliable pain assessment using the NRS
- •Pregnancy or lactation
- •History of previous lumbar spine surgery
- •Diabetes mellitus
- •Renal or hepatic impairment
研究组 & 干预措施
Group QIPB
Participants in this arm will receive an ultrasound-guided Quadro-Iliac Plane Block. The block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. A convex ultrasound probe will be placed at the level where the quadratus lumborum muscle (QLM) attaches to the iliac crest to visualize the erector spinae muscle (ESM) and the underlying QLM.
The block location will be confirmed by injecting 2 mL of isotonic solution at the QLM-iliac crest junction. Subsequently, 20 mL of 0.25% bupivacaine will be injected, and the spread of the local anesthetic between the ESM and QLM will be observed under ultrasound guidance. The block will be performed bilaterally with a total volume of 40 mL.
干预措施: Quadro-Iliac Plane Block (Procedure)
Group Control
结局指标
主要结局
Postoperative 48-Hour PCA Opioid Consumption
时间窗: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
QoR-15 Recovery Score
时间窗: Postoperative 24th and 48th hours
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
次要结局
- Dynamic and static NRS scores(0, 2, 4, 8, 16, 24, and 48 hours postoperatively)
- Total rescue analgesic dose(Postoperative 24th and 48th hours)
- Time of first request for rescue analgesia(Postoperative 48-Hours)
- Length of Hospital Stay(Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded (day).)
- Block and Opioid-Related Adverse Effects and Complications(Postoperative 48-Hours)
研究者
Merih Yıldız Eglen
Principal Investigator, MD
Bursa City Hospital