Investigation of the Effects of Quadro-Iliac Plane Block and Wound Infiltration on Postoperative Acute Pain After Single-Level Lumbar Discectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 24-hour cumulative opioid consumption
研究概览
简要总结
This prospective observational study aims to compare the effects of the Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI) on postoperative acute pain in adult patients undergoing elective single-level lumbar discectomy. QIPB is a newly introduced ultrasound-guided fascial plane block, and it is currently being used in routine clinical practice in our anesthesiology department as part of postoperative analgesia for lumbar spine surgery. Wound infiltration is a conventional method in which local anesthetic is injected into the surgical field at the end of the procedure.
In this study, eligible patients will be monitored prospectively without randomization or alteration of standard care. Postoperative pain scores, opioid consumption, nausea and vomiting, patient satisfaction, and recovery parameters will be evaluated during the first 24 hours after surgery. The study aims to provide real-world clinical evidence comparing these two analgesic techniques in lumbar discectomy patients.
详细描述
This prospective observational study aims to evaluate and compare the postoperative analgesic outcomes of two routinely used analgesic techniques-Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI)-in adult patients undergoing elective single-level lumbar discectomy. Both QIPB and WI are standard components of postoperative pain management in our hospital, and the type of analgesic technique administered to each patient is determined solely by the attending anesthesiologist based on routine clinical judgment. The research team does not influence clinical decision-making, perform block procedures, or modify any aspect of patient care. All interventions included in this study reflect standard institutional practice.
The primary objective is to compare cumulative opioid consumption during the first 24 hours after surgery between patients receiving QIPB and those receiving WI. Secondary objectives include evaluating postoperative pain scores, early recovery parameters, patient satisfaction, postoperative nausea and vomiting (PONV), rescue analgesic requirements, block-related complications, and hospital length of stay.
Clinical Routine and Analgesic Protocol
All patients will be managed according to the standard multimodal analgesia protocol routinely used in our neurosurgery operating room. Intraoperatively, intravenous tenoxicam 20 mg, tramadol 100 mg and dexamethasone 8 mg will be administered as part of routine analgesic and antiemetic care. Paracetamol 1 g IV will be given at the end of surgery and continued at regular intervals postoperatively. Rescue analgesia will consist of intravenous tramadol 100 mg infused over 30 minutes, with a maximum daily dose of 300 mg; if pain remains uncontrolled (NRS ≥4). All patients will receive intravenous morphine patient-controlled analgesia (Body Guard 575 Pain Manager) with a standard setting of 1 mg bolus dose, a 10-minute lockout interval, and a 4-hour limit set to 80% of the maximum allowable dose.
Block Techniques (Performed as Part of Routine Care)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged 18 to 80 years
- •Scheduled for elective single-level lumbar discectomy
- •ASA physical status I-III
- •Able to use patient-controlled analgesia (PCA)
- •Able and willing to provide written informed consent
排除标准
- •History of opioid use for longer than 4 weeks
- •Presence of chronic pain before surgery (e.g., migraine, fibromyalgia)
- •Alcohol or substance dependence
- •Known allergy or hypersensitivity to local anesthetics or opioids
- •Significant organ dysfunction (e.g., severe hepatic or renal disease)
- •Revision or multilevel spine surgery
- •Contraindications to regional anesthesia
- •Severe psychiatric disorders limiting cooperation (e.g., psychosis, dementia)
- •Pregnancy or breastfeeding
- •Hematologic disorders
研究组 & 干预措施
Group QİPB
Patients receiving ultrasound-guided Quadro-Iliac Plane Block with 30 mL of 0.25% bupivacaine per side (total 60 mL) as part of routine postoperative analgesia after single-level lumbar discectomy.
Group WI
Patients receiving ultrasound-guided wound infiltration with 20 mL of 0.25% bupivacaine into the surgical field at the end of surgery as part of routine postoperative analgesia after single-level lumbar discectomy.
结局指标
主要结局
24-hour cumulative opioid consumption
时间窗: postoperative day 1
Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).
次要结局
- Opioid-related adverse effects(Postoperative day 7)
- Length of hospital stay(Postoperative day 2-4)
- Time to first mobilization(Postoperative day 2-4)
- Block-related complications(Postoperative day 7)
- Number of patients requiring rescue analgesia(Postoperative day 1)
- 12-hour cumulative opioid consumption(postoperative 12th hour)
- Block performance time(intraoperative period)
- Postoperative pain scores (NRS at rest and activity)(postoperative day 1)
- Patient-reported quality of recovery (QoR-15 score)(Postoperative day 1 and at postoperative day 2-4 day)
- Postoperative nausea and vomiting incidence (PONV)(Postoperative day 1)
- Time to first PCA analgesic demand(Postoperative day 1)
- 12-hour cumulative opioid consumption(postoperative 12th hour)
- Block performance time(intraoperative period)
- Postoperative pain scores (NRS at rest and activity)(postoperative day 1)
- Patient-reported quality of recovery (QoR-15 score)(Postoperative day 1 and at postoperative day 2-4 day)
- Postoperative nausea and vomiting incidence (PONV)(Postoperative day 1)
- Time to first PCA analgesic demand(Postoperative day 1)
- Number of patients requiring rescue analgesia(Postoperative day 1)
- Time to first mobilization(Postoperative day 2-4)
- Block-related complications(Postoperative day 7)
- Opioid-related adverse effects(Postoperative day 7)
- Length of hospital stay(Postoperative day 2-4)
研究者
Elif Sarikaya Ozel
M.D.
Karabuk University