Analgesic Effect of Ultrasound Guided Caudal Block Versus Quadratus Lumborum Plane Block in Lumbar Spine Surgery in Adult Patients: A Double Blinded Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Time to first rescue analgesic request.
研究概览
简要总结
Postoperative pain is a common complication after lumbar spine surgery due to inherent tissue damage during surgical procedures.
Many analgesic options have been explored. Opioid analgesics carry the risk of respiratory depression.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are popular and widely used as first-line treatment for acute pain following spinal surgery, but can provide inadequate analgesia. High doses of NSAIDs have also been linked to non-unions in spinal fusion surgery.
Patient-controlled analgesia or epidural injection analgesia are usually used. One of US guided regional anesthesia methods is the ultrasound-guided caudal block that was first described by Klocke and colleagues in 2003.
One of the more recent techniques that has been described recently is quadratus lumborum plane block(QLB),that is posterior abdominal wall fascial plane block first described by Blanco in 2007.In this study we will compare between analgesic effect of ultrasound guided caudal block to that of ultrasound guided quadratus lumborum plane block as well as safety of both modalities in adult patients undergoing lumbar spine fixation surgeries.
详细描述
This study will be conducted at Fayoum University Hospital after the approval of the local institutional ethics committee and local institutional review board. The study design will be a randomized, double-blind, controlled study. A detailed informed consent form will be signed by eligible patients prior to enrollment and randomization.
Inclusion criteria:
Anesthesia procedure Patients will be randomly allocated into one of three parallel groups (37 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. opaque sealed envelopes will be used and opened in the operating room by a anesthesia resident who will be blinded to the study. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation. Patients will be randomized into three groups.
Group (D) patients who will receive caudal block. Group (QL) patients who will receive posterior quadratus lumborum plane block. Group (C) patients who will not receive any blocks. Preoperative assessment A preoperative patient visit will be done for medical history taking, clinical examination, reassurance, and explaining the method of anesthesia. The study protocol, caudal block, quadratus lumborum plane block and the numerical pain rating score score will be explained to each patient during the preanesthetic counselling. The patient's back will be examined to detect any spinal deformities . Patients will fast for about 6 to 8 hours for solid meals , for 4 hours for non clear liquids and for 2 hours for clear liquids before surgery.
Intraoperative management Monitoring equipment will be connected to the patients included pulse oximetry, non-invasive blood pressure monitoring, five-lead electrocardiogram and capnography. IV access will be established. Patients in the three groups will receive general anesthesia after 5 minutes of pre oxygenation with 100% O2. Anesthesia will be induced with intravenous fentanyl 1mcg/kg, propofol 2 mg/kg and atracurium 0.5 mg/kg. After oral endotracheal intubation, anesthesia will be maintained with isoflurane (1.2%_1.5%) in oxygen _air mixture and atracurium 0.1mg/kg with interval about 20 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be achieved using computer-generated random numbering of each study patient. opaque sealed envelopes will be used and opened in the operating room by a anesthesia resident who will be blinded to the study. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation. Patients will be randomized into three groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-60 years old), of either gender undergoing elective lumbar spine fixation surgery.
- •Patients with American Society of Anesthesiologists (ASA) physical status I-II.
排除标准
- •Include patients who refuse.
- •Patients with contraindications to regional anesthesia (eg, local infection at site of injection, coagulation abnormalities).
- •Patients with spinal deformities or previous lumbar disc surgeries.
- •Allergy to local anesthetics, mental disorders as well as drug abuse.
- •BMI more than 35
结局指标
主要结局
Time to first rescue analgesic request.
时间窗: first 24 hours
duration between time of introducing intervention and time of first analgesic request
次要结局
- Total opioid consumption used in first 24 hours .(for first 24 hours)
- Intraoperative fentanyl consumption.(during intra operative period)
- Intraoperative heart rate every 15 minutes.(during intra operative period)
- Intraoperative blood pressure every 15 minutes(during intra operative period)
- postoperative heart rate every 2h for 24h.(for first 24 hours)
- postoperative blood pressure every 2h for 24h.(for first 24 hours)
- Complications related as local anesthetic toxicity, nausea and vomiting.(for first 24 hours)
- The postoperative numerical pain rating score for 24 h(for first 24 hours)
- The postoperative numerical pain rating score for 24 h(for first 24 hours)
- Total opioid consumption used in first 24 hours .(for first 24 hours)
- Intraoperative fentanyl consumption.(during intra operative period)
- Intraoperative heart rate every 15 minutes.(during intra operative period)
- Intraoperative blood pressure every 15 minutes(during intra operative period)
- postoperative heart rate every 2h for 24h.(for first 24 hours)
- postoperative blood pressure every 2h for 24h.(for first 24 hours)
- Complications related as local anesthetic toxicity, nausea and vomiting.(for first 24 hours)
研究者
Atef Mohamed mahmoud
Associate professor of anesthesia
Fayoum University Hospital