Prospective Comparative Evaluation of Intra-operative and Postoperative Outcomes Associated With Opioid Free Versus Opioid Based Anesthesia Techniques in Patients Undergoing Elective Lumbar Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Consumption in the First 48 Hours
研究概览
简要总结
This prospective, observational, non-randomized clinical study aims to evaluate the intraoperative and postoperative effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia methods in adult patients undergoing lumbar spinal surgery. Patients will be managed according to routine clinical practice and assigned to one of three groups based on the analgesic strategy used by the attending anesthesiologist: (1) opioid-free anesthesia using multimodal agents and/or erector spinae plane (ESP) block; (2) ESP block plus intraoperative opioids; or (3) opioid-based anesthesia without regional blocks.
The primary objective is to compare postoperative pain control and opioid requirements within the first 48 hours after surgery. Secondary objectives include evaluating opioid-related side effects such as nausea, vomiting, pruritus, constipation, delayed mobilization, urinary retention, and postoperative complications classified according to the Clavien-Dindo system. Standard postoperative analgesia, including intravenous morphine patient-controlled analgesia (PCA), acetaminophen, and NSAIDs, will be provided for all patients.
The study aims to determine whether an opioid-free multimodal analgesic approach can reduce opioid consumption and related adverse effects while maintaining adequate analgesia in patients undergoing lumbar spinal surgery.
详细描述
Lumbar spinal surgery, including lumbar canal stenosis and lumbar disc herniation procedures, is frequently associated with significant postoperative pain. Opioids are commonly used for perioperative analgesia; however, they may lead to several adverse effects such as nausea, vomiting, pruritus, constipation, urinary retention, delayed mobilization, and, less commonly, respiratory depression. In recent years, opioid-sparing and opioid-free multimodal analgesia strategies have gained increasing interest in an effort to minimize these side effects while maintaining effective pain control.
This prospective, observational, non-randomized study will evaluate the intraoperative and postoperative outcomes of three different anesthetic approaches routinely used in clinical practice for adult patients undergoing lumbar spinal surgery. Patients will be allocated into groups based on the independent decision of the attending anesthesiologist; the research team will not influence the anesthesia plan.
Group 1 (Opioid-free anesthesia): Patients receive multimodal analgesia (including agents such as acetaminophen, lidocaine, magnesium sulfate, ketamine, esmolol, and dexmedetomidine) and may undergo an erector spinae plane (ESP) block or other trunk blocks. No intraoperative opioids are administered.
Group 2 (ESP + opioid group): Patients receive an ESP block and multimodal analgesia, with the addition of intraoperative opioids such as remifentanil or morphine, as determined by the anesthesiologist.
Group 3 (Opioid-based anesthesia): Patients receive opioid-containing analgesia without the use of ESP or other truncal regional blocks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Elective surgery only
- •Scheduled for elective lumbar spinal surgery (lumbar spinal stenosis and/or lumbar disc herniation)
- •ASA physical status I-III
- •No previous lumbar spine surgery
- •Able to provide written informed consent
- •BIS monitoring available and recorded
- •Ability to comply with postoperative pain assessment (NRS/VAS)
- •Stable hemodynamic status preoperatively
排除标准
- •Age younger than 18 or older than 75
- •Inability or unwillingness to provide informed consent
- •Severe psychiatric disease or cognitive impairment
- •Emergency surgery cases
- •BMI > 40 kg/m²
- •Pregnancy
- •Uncontrolled hypertension, arrhythmia, or severe cardiac disease
- •Renal failure
- •Chronic beta-blocker use
- •Coagulation disorders
- •Chronic alcohol dependence or substance use
- •Neurological deficits affecting perception of pain
- •Chronic pain syndrome (fibromyalgia, chronic LBP > 3 months)
- •Chronic gabapentinoid use
- •Known allergy to any anesthetic or analgesic agents used in the study
- •Local infection at the intended ESP block injection site
- •Intraoperative change in anesthetic technique that deviates from initial planned management
- •Pediatric patients (<18 years)
结局指标
主要结局
Postoperative Opioid Consumption in the First 48 Hours
时间窗: 0-48 hours after surgery
Total cumulative opioid consumption (morphine equivalents) within the first 48 postoperative hours, recorded via intravenous patient-controlled analgesia (PCA) and rescue opioid boluses. This measure evaluates the analgesic effectiveness of opioid-free versus opioid-containing intraoperative anesthesia strategies.
次要结局
- Total Non-Opioid Analgesic Consumption(0-48 hours)
- Postoperative Pain Intensity Assessed by Numerical Rating Scale (NRS)(0, 3, 6, 12, 24, and 48 hours postoperatively)
- Incidence of Opioid-Related Adverse Effects(0-48 hours)
- Postoperative Complications According to the Clavien-Dindo Classification(Within 30 days after surgery)
- Time to First Analgesic Request(Postoperative period (assessed every 6 hours during the first 48 hours after arrival in the recovery unit))
- Time to First Mobilization(From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours)
- Return of Bowel Function(Time from the end of surgery to the first documented bowel movement, assessed within the first 48 postoperative hours)
- Intraoperative Heart Rate(Intraoperative period)
- Patient Satisfaction Score(At 48 hours postoperatively)
- Length of Post-operative Hospital Stay(Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively)
- Intraoperative Analgesia Nociception Index (ANI) Values(hroughout the intraoperative period)
- Intraoperative Blood Pressure(Intraoperative Period)
- Intraoperative Oxygenation and Ventilation Parameters(Intraoperative period)
- Intraoperative Bispectral Index (BIS) Values(Intraoperative period)
- Intraoperative Urine Output(Intraoperative period (from induction of anesthesia, assessed every 30 minutes until the end of surgery))
研究者
Ulgen Zengin
Associate Professor of Anesthesiology, Principal Investigator
Marmara University