Evaluation of epidural ropivacaine with fentanyl and ropivacaine with dexmedetomidine for endoscopic lumbar spine surgery
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Intra Operative Pain
研究概览
简要总结
This proposed clinical study is a prospective, randomized, comparative trial designed to evaluate the efficacy and safety of two epidural drug combinations like Ropivacaine with Fentanyl versus Ropivacaine with Dexmedetomidine—in patients undergoing endoscopic lumbar spine surgeries. In the lumbar spine surgeries, particularly through the endoscopic approach, are known for advantages like minimal invasiveness, reduced tissue damage, and faster recovery. However, pain management remains a significant challenge, particularly in the early postoperative period. Effective analgesia not only reduces patient discomfort but also facilitates early mobilization, reduces hospital stay, and improves overall surgical outcomes.
Ropivacaine is a long-acting amide local anesthetic, is preferred due to its lower cardiotoxicity and motor blockade profile compared to bupivacaine. However, its effect can be further enhanced with the use of adjuvant drugs. Fentanyl is a synthetic opioid, is commonly used due to its rapid onset and synergistic analgesic effect when combined with local anesthetics. However, it is associated with opioid-related side effects like nausea, pruritus, urinary retention, and respiratory depression. Dexmedetomidine is an alpha-2-adrenergic receptor agonist, has gained attention as an adjuvant because of its sedative, analgesic, and sympatholytic properties without causing significant respiratory depression. It may also prolong the duration of sensory and motor block when used epidurally.
The objective of this study is to compare both combinations based on several critical parameters, including Intraoperative and postoperative analgesic efficacy, Time to onset and duration of sensory and motor blockade, Hemodynamic stability during and after surgery, Quality of sedation and patient comfort levels, Postoperative pain scores using standardized scales, Time to first rescue analgesia and total analgesic consumption and, incidence of adverse effects like hypotension, bradycardia, nausea, vomiting, and pruritus.
In this randomized study we will enroll patients who meet the inclusion criteria and are undergoing elective endoscopic lumbar spine procedures under epidural anesthesia. Patients will be randomly assigned to either group, and standardized protocols for anesthesia and postoperative care will be followed. The findings are expected to offer evidence-based guidance for selecting the most effective adjuvant in epidural anesthesia for spine surgeries. The ultimate goal is to Improve perioperative pain control, Enhance patient safety and satisfaction, Minimize opioid-related side effects and, Support early ambulation and faster recovery
This research may contribute to refining anesthetic protocols for minimally invasive spine procedures and establishing best practices for pain management in the neurosurgical and orthopedic fields.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18–65 years.
- •ASA physical status I–II.
- •Scheduled for elective endoscopic spine surgeries.
- •Provided informed consent.
排除标准
- •Known allergy to study drugs.
- •Coagulopathy or bleeding disorders.
- •Infection at the injection site.
- •Neurological or psychiatric illness.
- •Severe cardiorespiratory or renal disease.
结局指标
主要结局
Intra Operative Pain
时间窗: 0( at time of induction), 5 minutes, 10 minutes, 15 | minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, | 150 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes, and 12 hours.
次要结局
- 1. Onset & duration of analgesia(2. Hemodynamic stability)
研究者
Dr Tanmay Saxena
Care CHL Hospital, Indore
