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临床试验/NCT06662318
NCT06662318已完成不适用

Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study

Benha University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.

研究概览

简要总结

Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.

Opioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.

Non-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had LDD and required lumbar discectomy,
  • Patients are free of exclusion criteria and accepted to participate in the study.

排除标准

  • The presence of other indications for spinal surgery;
  • Obesity of grade ≥II;
  • Patients of ASA grade >II;
  • opioid dependence for preoperative pain;
  • The presence of other causes of preoperative pain;
  • The presence of preoperative psychiatric manifestations especially delirium and/or cognitive dysfunction;
  • The presence of contraindications for the use of the study drugs;
  • The presence of uncontrolled cardiac, renal, or hepatic disorders and essential hypertension.

研究组 & 干预措施

Group L

Active Comparator

干预措施: Lidocaine Hydrochloride (Drug)

Group D

Active Comparator

干预措施: Dexmedetomidine (Drug)

Group F

Active Comparator

干预措施: Fentanyl Citrate (Drug)

结局指标

主要结局

Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.

时间窗: 2 months

Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Azza Mahrous Shaffik

Clinical Lecturer of Anesthesia, Pain & ICU

Benha University

研究点 (1)

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