Analgesic Efficacy of Erector Spinae Plane Block with Dexmedetomidine and Dexamethasone As Adjuvants in Single to Three-Level Lumbar Spine Fusion
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). In the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. This possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery.
We try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.
详细描述
Regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. Erector spinae plane blocks (ESPB) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. This study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in ESPB improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. It will also assess the impact of these adjuncts on postoperative nausea and vomiting (PONV) and anti-emetic medication requirements. The study employs a randomized, double-blind design, with participants divided into two groups: ESPB without adjuvants (Group A) and ESPB with dexmedetomidine and dexamethasone (Group B). Primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (VAS) pain scores. The results of this investigation will provide valuable insights into the efficacy of ESPB with adjuncts in postoperative pain management in lumbar spinal fusion patients.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Spine Surgeon
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies
- •Aged 18 years or older
- •English-speaking patients
排除标准
- •Patients with surgical indications for infection, malignancy, or trauma
- •women who are pregnancy or breastfeeding
- •Patients with respiratory compromise
- •Patients who are smokers
- •Patients with allergies to local anesthetics, and/or opioid medications
研究组 & 干预措施
Group A (control)
Patients will receive an erector spinae plane block (ESPB) with 20 cc solution per single-shot injection comprised of 0.25% bupivacaine and 0.9% normal saline under ultrasound guidance to be administered bilaterally (40 cc total).
干预措施: Control (Standard treatment) (Drug)
Group B (Intervention)
Patients will receive ESPB with 20cc solution per single-shot injection comprised of 0.25% bupivacaine, 25mcg dexmedetomidine, and 5mg dexamethasone under ultrasound guidance to be administered bilaterally (40 cc total). This is in addition to the bupivacaine.
干预措施: Adjuvant analgesia (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: 24 hours postoperatively
measured in morphine milligram equivalents (MME)
次要结局
未报告次要终点
研究者
Paul S. Lee
Associate Professor
University of Southern California